Pharmaceutical sciences
Cosmetics
Evaluation and Q & C of Cosmetic Products
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Development Team
Principal Investigator
Dr. Vijaya Khader
Former Dean, Acharya N G Ranga Agricultural University Prof. Farhan J Ahmad Jamia Hamdard, New Delhi
Paper Coordinator Dr. Javed Ali
Jamia Hamdard, New Delhi
Content Writer Dr. Javed Ali
Jamia Hamdard, New Delhi
Content Reviewer Prof. B. Mishra
IIT, BHU
Pharmaceutical sciences
Cosmetics
Evaluation and Q & C of Cosmetic Products
0
Evaluation and Q & C of Cosmetic Products Content
Official method of analysis of cosmetics ingredients
Three main regulatory system on global level for cosmetic domain- Europe (EU), United States (US) and Japan
Specific legislation on ingredients
Sensorial tests by experts of cosmetic products
Rheological consideration of cosmetic product
Laboratory instrumental tests - Instrumental measurements associated with an evaluation by professional experts
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Introduction
Evaluation and quality control of cosmetic products is necessary to ensure its safety and efficacy and the raw materials used in manufacturing it. Efficient low cost and rapid method of evaluation of cosmetic is important as cosmetic product demand is increasing all over the world. Quality control of cosmetics keeps a check whether the standard features of the ingredients utilised in manufacturing cosmetics will be retained during the shelf-life of products.
1. Official method of analysis of cosmetics ingredients
It includes both qualitative and quantitative analysis to ensure that there is no harmful byproduct form during formulation procedure and the amount of ingredients is same as that for the formulation. As the maximum amount of ingredients is limited by legislation so quantitative determination of ingredients is essential. For example if a sunscreen preparation is labelled with specific sun protection factor (SPF) then quality control test has to ensure that the product contain same amount of UV filter as claimed for the formulation.
Analytical method employed should have the following properties;
● Accuracy: Quantity determined for ingredients in the sample should be close to the actual quantity added in formulating the product.
● Precision: If the procedure is repeated several times then it should give same value of analyte in the sample.
● Sensitivity: Analytical technique must be able to detect low quantity of substance in the sample as some byproduct formed during formulation or any contaminant could be very toxic
● Selectivity: The method utilized for detecting a particular compound must not be able to quantify other ingredient in the product as this will result in interference of the result.
● Robustness: If the method is slightly varied then it should not affect the accuracy of the result.
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● Other properties: Sample preparation should be simple and rapid, reagents utilized should be less and non-toxic. Automation should be of high level to get best result.
Analysis of cosmetic ingredients is not simple as the sample may contain variety of ingredients.
Also, the formulation needs extensive treatment like such as solubilization, purification and/or pre-concentration.
Analytes can be dissolved by using suitable reagent using heating, or exposure to ultrasound or microwave radiation. Sometime treatment with strong acid or base is also done. In some cases purification/pre-concentration of analytes is also done before analysis by using solid phase or liquid–liquid extraction. General analytical technique employed uses liquid chromatography (38%) followed by gas chromatography (16%) and other techniques as shown in figure 1.
Fig 1. Percentages of analytical techniques used for cosmetic analysis
38%
16%
15%
15%
8%
5% 3%
Contribution
Liquid chromatography Gas chromatography Other chromatography methods Molecular spectroscopy Electrochemical measurement atomic spectroscopy Other
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1.1. Perfume and aroma
Techniques utilized in analyzing perfume or aroma conventionally includes sample preparation by distillations namely vacuum, steam or hydro based. The analysis is performed by capillary GC, capillary GC–MS, capillary GC–FT–IR. New techniques and modification of the conventional techniques have been used in analysis and include;
• “Headspace solid phase microextraction (HS–SPME), headspace solid phase dynamic extraction (HS–SPDE) and headspace sorptive extraction (HSSE) (Source:
http://www.chemikinternational.com)”.
• Use of rapid extraction techniques such as supercritical fluid extraction (SFE), accelerated solvent extraction (ASE) and microwave-assisted extraction (MAE).
• GC (Fast GC) performs detection of analytes by minutes or seconds.
• Introduction of multidimensional gas chromatographic technique – MDGC has overcome the limitations of the heart-cut GC technique which is used to separate highly complex mixtures.
• Selectivity of detection can be increased by cyclodextrin derivatives when used as stationary phase for enantio-selective GC which causes separation of volatile racemates by chiral recognition.
1.1.1. Gas Chromatography and Gas Chromatography coupled with mass spectrometry
In cosmetics fragrance is quantified by separation techniques like chromatography. As the boiling point of fragrance chemicals is low so gas chromatography (GC) is best choice. Kovats Index (KI) of each compound is determined by using flame ionization (FID). KI is the measure of retention time of test hydrocarbon with respect to standard hydrocarbons. Each compound is
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identified by comparing experimentally measured KI with the standard value. Sometime GC coupled with mass spectrometry (MS) detector is used. This technique helps in identifying cosmetic ingredients like perfume.
Fragrances can be obtained from different sources like animal (eg., musk, civet, ambergris etc), plant (eg., sandalwood, lemon cinnamon etc.) or can be obtained from synthetic chemical like cinnamoyl alcohol. Extraction procedure applied for all perfumes is described below.
1.1.2. Solvent extraction
Solvents like hexane, methanol or ethanol are generally used to extract the fragrance from plant or animal. Solvent is removed by distillation to obtain concentrate. From the extract even more pure fragrance concentrate can be obtained by treating the concentrate with cold ethanol. The absolute extract so obtained is the purest form of an essential oil. For thermo labile and high boiling point fragrance chemicals, this method is very helpful because steam distillation can degrade the fragrance material.
1.1.3. Microwave Assisted Extraction (MAE)
Microwaves are electromagnetic waves produced in the range of 300 MHz to 300 GHz.
Microwave has the property of efficient volumetric heat production so it is better technique of extraction than other thermal technique. MAE can extract variety of soluble material into the extracting fluid. This technique is superior to distillation as extraction is performed in closed container with magnetic stirrer where temperature distribution is high. For example volatile oil from rose is extracted by MAE from rose buds using acetone and hexane as solvents. Rose is natural source of geraniol and is important flavour ingredient.
1.1.4. Solid Phase Microextraction (SPME)
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SPME technique is solvent free extraction technique. In this technique product to be determined are absorbed on fused silican fibre which is coated with polymer. Analytes are then desorbed into a chromatographic injection port. This method is very simple, sensitive and quick to sample preparation and suitable for analysis of monoterpenes in tree tissues. Needle is coated with absorbent and depending upon the type of absorbent volatiles having affinity to the absorbent is migrated on to it and absorbed there. This method is used to analyze pine oil which is used as starting material in fragrance industry. Pine oil contains α-(~80%) and β-pinene (~5%) out of which α-pinene is the substance of interest in industry as it is used as the starting material in the synthesis of borneol, camphor and terpineols.
1.1.5. UV filters
There is no official method to determine UV filter but as there maximum content is regulated by the legislation so analytical method to control these products are essential. More about UV filters is discussed in the section 1.1.6.
1.1.6. High performance liquid chromatography (HPLC)
HPLC is used in the analysis and purification of soluble compounds like drug and proteins.
HPLC can analyze several biomolecules. For example peptides and proteins, amino acids, carbohydrates, nucleic acids and lipids. Liquid chromatography is used to determine UV filter e.g., para-amino benzoic acid. It is not easy to determine UV filter in cosmetic product as there previous separation from cosmetic product is required. GC can provide higher resolution than liquid chromatography in quantitative determination of UV filter but later is preferred as they can deal more effectively with low volatile materials. Generally reverse phase column (silica columns for example C18 or C8 type) is utilized in separation as separation is faster. Normal- phase columns like silica gel (Si) is not used. LC-MS is more sensitive than liquid chromatography for quantitative determination with high accuracy. By-products of photo- degradation of the UV filters is also studied by this separation method. UV-visible detector is
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mostly used in determination of UV filters. Solvent used as mobile phase in chromatography include water, acetonitrile, methanol and tetrahydrofurane or combinations threreof. Peak tailing can be prevented in analysis of UV filter includes acetic acid, ethylenediaminetetraacetic acid, perchlorate and tetra methyl ammonium chloride, stearyl trimethyl ammonium chloride.
2. Three main regulatory system on global level for cosmetic domain- Europe (EU), United States (US) and Japan
Every country has their own regulatory bodies which controls the product quality before it finally reaches into the market apart from protecting health and interest of the consumer. If a cosmetic product meets all the requirements and compliance in a particular country then as there is enough difference in regulatory requirement from country to country, product may not meet the standards set by other country. However good manufacturing guidelines and product labelling is what is similar from country to country.
2.1 European regulatory system
New Regulation EC 1223/2009 fully replaced the old directive 76/768/EEC from 2013.
Definition of cosmetics as per European regulation is “cosmetic product shall mean any substance or mixture intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition (Source: International cosmetic regulatory framework;
http://www.cosmeticsciencetechnology.com).
This directive gives a positive definition by including three different characteristics:
- Cosmetic product: a cosmetic can not only be a mixture, which is what we may traditionally regard it as, but it can also be a single ingredient.
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- Area of application: a list of areas where a cosmetic product can be applied or used is given, in which all areas can be considered as external in so much as mucous membranes can be considered as outwardly.
- Function: arguably the most interesting part of the definition as it separates the cosmetic product from any other kind of products based on its intended use.
Following ingredients have been included into the directive;
- Prohibited substances: including all substances which cannot be part of the composition of a cosmetic product. This list constitutes Annex II of the cosmetics directive.
- Regulated substances: composed of several lists in which restrictions are set for certain allowed substances in regards to the concentration in the finished product relating also to their function.
The lists include:
• Substances included in Annex III
• Colouring agents included in Annex IV.
• Preservatives included in Annex VI
• UV filters included in Annex VII
For every cosmetic product the following items must appear on the label:
- Name and address of the manufacturer or responsible person. As if hidden, this simple sentence has a deep significance within the regulation. It introduces the concept or “responsibility”. For any cosmetic product in the market there is, according to this, a person who will and must answer to any issues derived from the cosmetic product. This responsibility could also turn into liability if the cosmetic product is not only found to be noncompliant with the directive, but also if it poses a health risk for the consumer.
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- The nominal content at the time of packaging, in weight of volume.
- The minimum durability date of the product. This can appear as an actual date, as a month/year or, for products with a shelf life of over 30 months, as what is called a PAO (period after opening), which is an indication of time period during which the product can be used without harm by the consumer.
- Particular precautions, which may have to do with the presence of a certain ingredient, such as the ones in the regulated lists, a specific presentation or the packaging.
- The batch number of manufacture. This assures traceability of the finished product and is deeply related to the exercise of good manufacturing practices.
- The function of the product should be mentioned if not clear from the presentation.
- The list of ingredients should also be mentioned.
In new regulation two more ingredients have been added;
1) CMR substances – it includes carcinogenic, mutagenic or reprotoxic when used, and their inclusion is initially prohibited. Exceptions can be made if the scientific reviews deem it safe for human use in cosmetic form and there are no possible alternatives to their use.
2) Nanomaterials – enough data must be available that ensures its safety in human cosmetics.
They must also be listed as such in the label so as to inform the consumer of their presence and allow for an informed decision.
2.2 United States of America regulatory system
As per US FDA cosmetics can be defined as “Articles intended to be rubbed poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for
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cleansing, beautifying, promoting attractiveness, or altering the appearance and articles intended for use as a component of such articles (Source: www.fda.gov).
Ingredients
The FDA has prohibited the use of 12 ingredients. The rest are to be used only when considered safe under normal use. Liability lies with the person responsible for the marketing of the cosmetic. Nanomaterials are allowed, but FDA encourages previous knowledge.
Labelling and marking The label must include:
- Name and address of business - Net content
- Any instructions deemed necessary so as to not pose any risk.
A misbranded product is the one bearing an incorrect label for non-inclusion of relevant information or for misleading.
Animal testing
The FDA does not support regarding animal testing. Neither in favor nor against. It is solely left on the judgment of the manufacturer.
So as to assure the safety of the cosmetics on human health the FD&C Act gives the definition of adulterated cosmetic as that “which bears any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed or are customary or usual”. A list of ingredients which are banned to be used in cosmetic is included in the Federal Regulations and include only 12 items. The FDA also encourages manufacturers to inform when using a new nanomaterial and to provide the scientific proof of its safety beforehand. Cosmetic product must be fully labelled and failure to do so that product is regarded as misbranded. A misbranded
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cosmetic is so when the “labelling is false or misleading in any particular”, or “if in package form unless it bears a label containing the name and place of business of the manufacturer, packer, or distributor, and accurate labelling of the quantity of the contents in terms of weight, measure or numerical count”.
2.3 Japan regulatory authority
Japanese cosmetics is regulated by the Ministry of Health, Labour and Welfare (MHLW) by the law of Pharmaceutical Affairs. Products labelling is regulated by law. Products must contain all the ingredients excluding certain items that may not appear in the labelling. Product that does not meet regulatory standard is prohibited. Any false or misleading statement and unapproved claims should be regulated. The law defines cosmetic as “articles with mild action on the human body, which are intended to be applied to the human body through rubbing, sprinkling or other method, aiming to clean, beautify and increase the attractiveness, alter the appearance or to keep the skin or hair in good condition” (Source: Guidebook for exporting/importing cosmetics to Japan).
Japan has list of ingredients which are not to be used in cosmetics, list of UV filters and preservatives. It is solely on the manufacturer to ensure the safety of cosmetic product. There is no requirement to take pre-market approval and license from the Ministry of Health, Labor and Welfare. Japanese company just provide notification of product brand prior to manufacturing.
The required labeling items for cosmetics and cosmetic soaps are as follows.
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3. Specific legislation on ingredients
Specific legislation on ingredients is there to assure three important features namely safety, efficacy and quality of cosmetic products. Both safety and efficacy is considered under following conditions:
– The final product must be in accordance with composition designed by the manufacturer and should be in a perfect state.
– The cosmetic has to be applied by the user under the normal given conditions.
Quality and safety is two different thing. Both can cause adverse effect on user. But if product is not meeting quality then that specific batch is withdrawn from market and if product is not safe then product is completely withdrawn from the market.
Problem related with quality is evident (separation of phases, rarefaction of the fat phases, etc.) and user can avoid such product. Sometime product not meeting quality standard does not
cosmetics
• Product name by type
• Brand name
• Name and address of primary distributor
• Content (weight or capacity)
• Country of origin
• Manufacturing number or code
• List of ingredients as required by the MHLW
• Expiration date, for a cosmetic designated by the MHLW
• Precautions on usage or storage
• Information contact
Soaps
• Name and address of primary distributor
• Brand name
• The word "Soap"
• List of ingredients as required by the MHLW
• Manufacturing number or code
• Expiration date, for a designated cosmetic soap
• For those products manufactured by a frame mixing method, a term to that effect
• Standard weight per unit
• Country of origin
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adversely affect the users. For example if product is not properly labelled then it will not cause any adverse effect but if sun protecting factor is wrongly mentioned then it can cause local erythema to user who overexpose themselves to sun.
The main aspect of quality control of cosmetic is related with the ingredients which the product contains. There are the requirements which needs to be established such as;
– Legal requirements, to prohibit narcotic and/or psychotropic substances, new or toxic substances that could be allowed/restricted in the formulation of cosmetic products.
– Public health requirements, such as sunscreen products to prevent sunburn, pediculicide products, etc.
– Products, considered in principle as cosmetics, but which could exert a marked pharmacological effect.
– Toxicological aspects.
Authorities also establish the labelling requirements of ingredients composition, warnings about the presence of certain ingredients, etc.
Article 5a of the EU Cosmetics Directive (Council Directive 76/768/CEE), contains the information of each ingredients, its function, restriction and warning etc. The article defines cosmetic ingredients as “any chemical substance or preparation of synthetic or natural origin, except for perfume and aromatic compositions, used in the composition of cosmetic products (Source:http://www.linguee.nl).” Any impurity present is not considered as the ingredient.
The EU Cosmetics Directive, in its Article 4b, limits the use of certain ingredients in cosmetic products like CMR substances which are carcinogenic, mutagenic or toxic for reproduction as per Council Directive 67/548/EEC, which regulates the classification, packaging and labelling of dangerous substances placed on the market. However substance which comes under category 3 can be used in cosmetics if the substances after evaluation by Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP) found acceptable for use in cosmetic product.
As per the US FDA product labelling must contain first the name of active ingredient and the quantity of each one of them. Next ingredients with name under inactive ingredient is mentioned.
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Certain restricted substances in cosmetic products by FDA includes bithional, chloroform, cattle material, chlorofluorocarbon propellant, vinyl chloride etc. Some ingredients have been regarded as unsafe by Code of Federal regulation (CFR) to be used in cosmetic product and is mentioned in table 4.
Table 4. Unsafe ingredients for use in cosmetic by CFR
Ingredients Use Concerns
Chloroacetamide Preservative Skin sensitization Ethoxyethanol and its
acetate
Solvent Reproductive and
developmental toxicity HC blue No. 1 Hair coloring agent Carcinogenicity p-hydroxyanisole Antioxidant Skin bleaching
Pyrocatechol Hair dye Carcinogenicity
4-methoxy-m-
phenylenediamine and its hydrochloride and sulphate
Hair dye and skin caring preparation
Carcinogenicity in leave on product
As per Japan comprehensive licensing system each ingredient used in cosmetic has to be pre- approved by Ministry of Health and Welfare (MHW). Japan also has the list of 30 prohibited ingredients as approved by MHW in Standards for Cosmetics notification. Apart from this, the list also contain 20 restricted ingredients, 40 preservatives and 30 UV filters. As per the Standards for Cosmetics, cosmetic must not contain any drug ingredients (except those mentioned in appendix 2) and ingredients that do not meet the standards of biological material.
Cosmetic product must not contain any ingredients in higher amount as mentioned in appendix 2.
MHLW has given list of 138 ingredients that must be included on the label.
4. Sensorial tests
Sensory analysis is defined as analyzing the product through evaluating the properties traceable by 5 sense organs. It includes observing organoleptic property such as such as color, odor, taste, touch, texture and noise. Volunteer participating in such test can give information about smell, looks, form and consistency and other characteristics user experiences when using this product.
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The sensorial features are related to the raw material used in the formulation and the packaging.
For example emollient influence the tactile sense. Silicones and Polymethyl Methacrylate are other sensorial modifier. First sense to be used is the vision so packaging of cosmetics should be appealing as this gives the first impression to the consumer. After that smell is used. Sensorial features is of great importance in market success of the cosmetic products. These sensorial characteristics should be present till the shelf-life of the product. Lab for the sensorial analysis must have the following area;
A room for the analyst who is team leader
A conference room
A room for preparing sample
An area dedicated to volunteers who analyses the product characteristics The laboratory should be located in an easy access place.
The temperature and humidity of lab should be around 22 ºC and at 45% respectively.
5. Rheological consideration of cosmetic product
Majority of companies use viscometer to evaluate and predict the stability of the cosmetic product by assessing rheological characteristics.
Rheology is the study of flow of materials under externally applied forces. Three parameters discussed in rheology include shear stress, shear rate and viscosity. Shear stress is defined as force applied on the surface per unit area.
σ = F / A Where:
σ refers to shear stress, unit Pascal (Pa) F refers to force, unit Newton (N) A refers to area (m2)
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Shear rate can be calculated by dividing velocity of material with film thickness. Viscosity can be defined as the resistance offered to the flow of the liquid. Viscous formulation flow is lesser than the others.
The viscosity can be obtained by dividing shear stress with shear rate:
η = σ / γ Where:
η is the viscosity (Pa.s) σ is the shear stress (Pa) and γ is the shear rate (s-1)
There can be two types of material newtonian and non-newtonian. In case of former shear stress is proportional to shear strain. Non-newtonian material includes plastic, pseudoplastic, dilatant, thixotropic and rheopectic fluids. Viscosity is constant in case of newtonian flow which is independent of time and temperature.
Fig 2. Flow of newtonian material
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Non-newtonian material does not show this type of flow. A material is said to show plastic flow if shear rate is equal to zero with initial application of shear stress and after that shear rate becomes proportional to shear stress. Material starts flowing after sufficient application of force.
Yield values refers to force necessary to make plastic material to flow.
In case of non-newtonian material if viscosity decreases with shear rate then the material is said to exhibit pseudoplastic flow. If the viscosity increases with shear rate then the material is said to exhibit dilatant flow.
Fig. 3. Flow of plastic material
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Fig. 4. Flow of dilatant material
Fig 5. Flow of pseudoplastic material
During stability assay rheological test is very useful at initial phase of formulation development.
Periodically viscosity of formulation is measured under stress test which can be done with the help of viscometer or rheometer. Viscosity of the material under stress condition at different time
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point is compared with initial value and also with control formulation. Increase or decrease in the viscosity is then useful in assessing the attribute of the formulation. Also during the experiment hysteresis loop can be obtained which helps in analyzing spread ability of the formulation.
Larger the hysteresis area, higher will be the spread ability.
Fig 6. Hysteresis loop showing flow of material
Higher viscosity of the emulsion formulation retards the phase separation. Low viscosity of emulsion system can cause coalescence of dispersed phase.
6. Laboratory instrumental tests
Different instruments associated with an evaluation of cosmetic preparation by professional experts are discussed in Table 5
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Table 5. Instruments associated with the evaluation of cosmetic preparation at laboratory scale
Instrument Description
Penetrometers Direct reading unit accurately determines
consistency of waxes, highly viscous material as well as food, cosmetic, and pharmaceutical products.
Scott Volumeter Used to determine "apparent density" of a variety of free flowing powders.
Spectro-Guide
Total appearance control. It measures color and gloss all in one unit.
CT-3 Texture analyzer Subjects testing samples to compression forces using a probe, or tension forces using grips.
SS Fineness of Grind Gage The Fineness of Grind Gage is used to indicate the fineness of grind or the presence of coarse particles or agglomerates in a dispersion.
Novolite New generation of glossmeters combine
functionality & accuracy with a modern design that uses lightweight and durable materials.
Falling Ball Viscometer Measures viscosity of less viscous material.
Meinzer II Sieve Shaker This lightweight and portable sieve shaker gives precise repeatable results.
Powder Flow Tester Rapid analysis of powder flow behavior DV3T Rheometer
Programmable rheometer ideal for analyzing fluids in various applications.
Consistometer
Bostwick Type stainless steel device designed to determine the flow of a standard volume of thick liquid or semisolid under its own
weight.
EZ Zahn Dip Cups The most popular type of viscosity measuring
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instrument as a national and international standard.
Weight Per Gallon Cups
Quick and accurate determination of the weight per gl, & the specific gravity of paints, lacquer, pastes, semi-pastes, and other liquid materials.
GTI MiniMatcher® MM-4e
Matches the color of the inks, paints, plastics, textiles, paper and other colored materials.
Rapid Flash Point Tester
This semiautomatic instrument is used for determining the flash point temperature / combustibility of flammable liquids.
Dial Reading Viscometers
Extremely quiet operation and greater versatility.
PDV-100 Portable/disposable viscometer used for the
rapid and accurate determination of the viscous properties of Newtonian and Non- Newtonian fluids.
Lab Roller Mill
Ideal for blending and milling pigment, paint, ink, etc in small batches.
