Crospovidone Manufacturers, with SDS GHS MSDS Sheet
Supplier, Manufacturer, Exporter of Crospovidone Muby Chemicals of Mubychem Group, established in 1976, is the original manufacturers of Specialty Chemicals, Pharmaceutical Excipient, Fragrance Food & Flavor chemicals, Reagent Grade Chemicals, Shale Gas Fracturing Chemicals in India. Mubychem Group has several manufacturing facilities spread across Western India and world wide contacts and toll manufacturers. We are exporting globally to countries like USA, Canada, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Cameroon, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Dubai, Korea, Vietnam, Thailand, Malaysia, Indonesia, Australia, China, Germany, France, Italy, Portugal etc.
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Crospovidone: CAS Number: 9003-39-8, EINECS EC Number: yy, Molecular Formula: yy, Molecular Weight: yy, HS Code ---**
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SDS MSDS Sheet of Crospovidone Manufacturers
BP Ph Eur USP NF FCC Food Grade Pure Suppliers
Specifications of Crospovidone USP NF Grade:
1-Vinyl-2-pyrrolidinone homopolymer --- CAS 9003-39-8.
Crospovidone is a water-insoluble synthetic cross-linked homopolymer of N-vinyl-2-pyrrolidinone. It contains NLT 11.0% and NMT 12.8% of nitrogen (N), calculated on the dried basis. Two types of Crospovidone are available, depending on the particle size: Type A and Type B.
A. Infrared Absorption: Previously dried in a vacuum at 105C for 1 h.
Sample: 1 g
Analysis: Suspend the Sample in 10 mL of water, add 0.1 mL of 0.1 N iodine, and shake for 30 s. Add 1 mL of starch TS, and shake.
Acceptance criteria: No blue color develops.
C. To 10 mL of water add 0.1 g and shake. A suspension is formed, and no clear solution is obtained within 15 min.
Sample: 20 g of the dried substance.
Analysis: Clean and dry the analytical sieves used in the analysis by washing the sieves in hot water. Allow to dry overnight in a drying cabinet at 105°. Place the Sample in a 1000-mL conical flask, add 500 mL of water, and shake the suspension for 30 min. Pour the suspension through a 63-micro-m analytical sieve, previously tared, and rinse the sieve with water until the filtrate is clear. Dry the sieve and sample residue at 105C for 5 h in a drying cabinet without circulating air. Cool in a desiccator for 30 min, and weigh.
Calculate the percentage sieving residue fraction of sample particles having a diameter of more than 63 µm:
Result = [( m1 − m3 ) × 100]/ m 2
m1 = mass of the sieve and sample residue, after drying for 5 h (g)
m3 = mass of the sieve (g)
m2 = initial mass of the sample, calculated on a dried basis (g)
Acceptance criteria: If the sieving residue fraction is more than 15%, the substance is classified as Type A; if the sieving residue fraction is NMT 15%, the substance is classified as Type B.
Sample: 0.1 g
Analysis: Proceed as directed, using the Sample. In the Procedure, omit the use of hydrogen peroxide, and use 5 g of a powdered mixture of potassium sulfate, cupric sulfate, and titanium dioxide (33:1:1), instead of potassium sulfate and cupric sulfate (10:1). Heat until a clear, light green solution is obtained. Heat for an additional 45 min, and proceed as directed for Procedure, beginning with “Cautiously add to the digestion mixture 70 mL of water”.
Acceptance criteria: 11.0%–12.8% on the dried basis.
Residue on Ignition: NMT 0.1%, determined on 1.0 g
Peroxides: To pass the test.
Acceptance criteria: NMT 0.35. For Type A, this corresponds to NMT 400 ppm expressed as H2O2 ; for Type B, this corresponds to NMT 1000 ppm expressed as H2O2.
Vinylpyrrolidinone: To pass the test by chromatogram.
Acceptance criteria: The area of the peak from the Sample solution is NMT the area of the principal peak from Reference solution A (NMT 10 ppm).
Loss on Drying: Dry 0.5 g at 105C to constant weight: it loses NMT 5.0% of its weight.
Water-Soluble Substances: To pass the test
Acceptance criteria: The weight of the residue does not exceed 75 mg (1.5%).
Packaging and Storage: Preserve in tight containers.
Labeling: The label states the type (Type A or Type B).
Specifications of Crospovidone BP, Ph Eur:
(C6H9NO) --- (111.1) --- CAS 9003-39-8
Action and use: Excipient in pharmaceutical products.
Cross-linked homopolymer of 1-ethenylpyrrolidin-2-one.
Content: 11.0 per cent to 12.8 per cent of N (Ar 14.01) (dried substance).
2 types of crospovidone are available, depending on the particle size: type A and type B.
Appearance: Hygroscopic, white or yellowish-white powder or flakes.
Solubility: Practically insoluble in water, in ethanol 96 per cent and in methylene chloride.♦
A. Infrared absorption spectrophotometry.
B. Suspend 1 g in 10 mL of water, add 0.1 mL of 0.05 M iodine and shake for 30 s. Add 1 mL of starch solution and shake. No blue colour develops within 30 s.
C. To 10 mL of water, add 0.1 g and shake. A suspension is formed and no clear solution is obtained within 15 min.
D. The analytical sieves must be clean and dry. For this purpose the sieves are washed in hot water and allowed to dry overnight in a drying cabinet at 105 °C.
To pass the 63 microM sieve test. If the sieving residue fraction is more than 15 per cent, the substance is classified as type A; if the sieving residue fraction is less than or equal to 15 per cent, the substance is classified as type B.
Peroxides: Type A: maximum 400 ppm expressed as H2O2; type B: maximum 1000 ppm expressed as H2O2.
Water-soluble substances: Maximum 1.5 per cent.
Impurity A by Liquid chromatography: Impurity A: maximum 10 ppm.
Loss on drying: Maximum 5.0 per cent, determined on 0.500 g by drying in an oven at 105C.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.
Place 0.100 g of the substance to be examined (m mg) in a combustion flask and add 5 g of a mixture of 1 g of copper sulfate pentahydrate, 1 g of titanium dioxide R and 33 g of dipotassium sulfate, and 3 glass beads. Wash any adhering particles from the neck into the flask with a small quantity of water. Add 7 mL of sulfuric acid, allowing it to run down the inside wall of the flask. Gradually heat the flask until the solution has a clear, yellowish-green colour, and the inside wall of the flask is free from carbonised material, and then heat for a further 45 min. After cooling, cautiously add 20 mL of water, and connect the flask to the distillation apparatus, which has been previously washed by passing steam through it. To the absorption flask add 30 mL of a 40 g/L solution of boric acid R, 0.15 mL of bromocresol green-methyl red solution and sufficient water to immerse the lower end of the condenser tube. Add 30 mL of strong sodium hydroxide solution through a funnel, cautiously rinse the funnel with 10 mL of water, immediately close the clamp attached to the rubber tube, then start the distillation with steam to obtain 80-100 mL of distillate. Remove the absorption flask from the lower end of the condenser tube, rinsing the end part with a small quantity of water and titrate the distillate with 0.025 M sulfuric acid until the colour of the solution changes from green through pale greyish-blue to pale greyish red-purple. Carry out a blank determination and make any necessary correction.
1 mL of 0.025 M sulfuric acid is equivalent to 0.700 mg of N.
In an airtight container.
The label states the type of crospovidone (type A or type B).
Polyvinylpolypyrrolidone FCC Food Grade:
Crospovidone; PVPP; 1-Vinyl-2-pyrrolidone Crosslinked Insoluble Polymer
Polyvinylpolypyrrolidone occurs as a white to off white, hygroscopic, free-flowing powder. It is a crosslinked homopolymer of purified vinylpyrrolidone, produced catalytically. It is insoluble in water and in other common solvents.
Function: Clarifying agent; stabilizer.
Identification: Add 0.1 mL of iodine TS to a suspension of 1 g of sample in 10 mL of water, and shake the mixture for 30 s. The reagent is discolored (distinction from polyvinylpyrrolidone, which produces a red color). Add 1 mL of starch and shake the mixture. No blue color appears.
Assay: Not less than 11.0% and not more than 12.8% of nitrogen (N).
Lead: Not more than 2 mg/kg.
pH of a 1:100 Suspension: Between 5.0 and 11.0.
Residue on Ignition: Not more than 0.4%.
Soluble Substances: Not more than 0.5% in water, and not more than 1.0% in an acid–alcohol medium.
Unsaturation: (as vinylpyrrolidone) Not more than 0.1%.
Water: Not more than 6.0%.
For Original Monographs of IP Indian Pharmacopoeia BP British Pharmacopoeia USP US Pharmacopoeia FCC Food Grade product, please check with the respective web-pages or books.
We manufacture and supply as under:
Ambernath Mumbai, Ankleshwar Gujarat, India
TEL: (OFFICE) +912223770100, +912223726950
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Last 26 August, 2022
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Crospovidone SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 11-Oct-20
1. PRODUCT DESCRIPTION
Product Name & Other Names: Crospovidone
CAS Number: 9003-39-8
EINECS EC Number: -
Molecular Weight: -
Molecular Formula: (C6H9NO)n
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Supplier: As per letterhead.
2. HAZARD IDENTIFICATION
GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Hazard Class and Category Code(s), Regulation (EC) No 1272/2008 (CLP)
Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008.
This substance is not classified as dangerous according to Directive 67/548/EEC.
Labeling as per GHS & Regulation EC 1272/2008 (CLP) & GHS
GHS Label Elements
Signal Words: None
Hazards not otherwise classified (HNOC):
May causes mild skin irritation.
May causes mild eye irritation, if exposed in large quantity.
P261: Avoid breathing dust/fume/gas/mist/vapors/spray.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
P302+P352 - IF ON SKIN: Wash with plenty of soap and water.
P303+P361+P353 - IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower.
P304 + P340 - IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P305 + P351 + P338 - IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+313: If eye irritation persists get medical advice/attention.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Product Name & Other Names: Crospovidone
CAS Number: 9003-39-8
4. FIRST AID MEASURES
Always get medical attention after the first aid is over.
Emergency and First Aid Procedures:
Eyes - Flush with water for at least 15 minutes, raising and lowering eyelids occasionally. Get medical attention if irritation persists.
Skin - Thoroughly wash exposed area for at least 15 minutes. Remove contaminated clothing. Launder contaminated clothing before reuse. Get medical attention if irritation persists.
Ingestion - If swallowed, if conscious, give plenty of water. Immediately call a physician. Never give anything by mouth to an unconscious person.
Inhalation - Remove to fresh air. Give oxygen if breathing is difficult; give artificial respiration if breathing has stopped. Get medical attention.
5. FIREFIGHTING PROCEDURES
Extinguisher Media: Use media suitable to extinguish surrounding fire. Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.
Flammable Limits in Air % by Volume: N/A
Special hazards arising from the substance or mixture: Carbon oxides, Nitrogen oxides (NOx)
Special Fire-fighting Procedures: Firefighters should wear full protective equipment and NIOSH approved self-contained breathing apparatus.
Special Information: In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full face piece operated in the pressure demand or other positive pressure mode. At high temperatures under fire conditions, it may produce toxic or irritating fumes.
6. SPILL OR LEAK PROCEDURES
Personal precautions, protective equipment, and emergency procedures: Avoid breathing dust/fumes/gas/mist/vapors/spray. Ensure adequate ventilation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Restrict unprotected personnel from the area. Prevent any contact with hot surfaces. Do not approach facing the wind. Do not touch the spilled material.
Environmental precautions: Do not let the product enter drains, soil, or water sources.
Methods and materials used for containment Cleanup procedures and Storage: Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g. sand, earth, diatomaceous earth, vermiculite). Vacuum or sweep-up and remove to an approved disposal container.
7. SPECIAL PRECAUTIONS
Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. Wash thoroughly after handling. Do not drink, eat, or smoke while handling. Avoid contact with skin, eyes, and clothing. Minimize dust generation. Avoid breathing dust/fumes/gas/mist/vapors/spray. Avoid contact with eyes, skin, and clothing. Keep container tightly closed. Avoid ingestion and inhalation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Prevent any contact with hot surfaces.
Conditions for safe storage, including any incompatibilities: Store cold to warm conditions, dry and ventilated area away from heat sources and protected from sunlight in tightly closed original container. Keep air contact to a minimum. Do not leave the material container open. Store protected from heat, sparks and ignition sources and incompatible materials. Avoid contact with skin and eyes. Avoid inhalation of dust/mist/vapor. Do not store with incompatible materials like strong oxidizing and reducing agents, Strong acids and bases.
8. SPECIAL PROTECTION INFORMATION
Airborne Exposure Limits: None established. Ensure adequate ventilation. Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below recommended exposure limits. If user operations generate dust, fume, or mist, use ventilation to keep exposure to airborne contaminants low.
Respiratory Protection (Specify Type): None needed under normal conditions of use with adequate ventilation. NIOSH approved equipment should be worn if PELs are exceeded.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures as low as possible. Local exhaust ventilation is generally preferred because it can control the emissions of the contaminant at its source, preventing dispersion of it into the general work area.
Personal Respirators (NIOSH Approved): For conditions of use where exposure to dust or mist is apparent and engineering controls are not feasible, a particulate respirator may be worn. For emergencies or instances where the exposure levels are not known, use a full-face positive-pressure, air-supplied respirator.
Skin Protection: Wear protective gloves and clean body-covering clothing.
Eye Protection: Use chemical safety goggles and/or full face shield where dusting or splashing of solutions is possible. Maintain eye wash fountain and quick-drench facilities in work area.
Other Control Measures: Maintain good housekeeping in work area. Dust deposits on floors and other surfaces may pick up moisture and cause the surfaces to become slippery and present safety hazards. Handle in accordance with good industrial hygiene and safety practice. Wash hands after handling.
9. PHYSICAL DATA
Appearance and Odor: Solid beige powder.
Odor: Odor not defined.
Odor threshold: Not available.
pH: 5-8 at 10% water solution.
Relative density: Not available.
Melting point/freezing point: Not available.
Initial boiling point and boiling range: Not available.
Flash point: Not available.
Auto-ignition temperature: Not available.
Decomposition temperature: Not available.
Upper/lower flammability or explosive limits: Not available.
Vapor pressure: Not available.
Vapor density: Not available.
Evaporation rate: Not available.
Flammability (solid, gas): Not available.
Partition coefficient: n-octanol/water: Not available.
Solubility(ies): Not available.
Viscosity: Not available.
Molecular Weight: -
Molecular Formula: (C6H9NO)n
10. REACTIVITY DATA
Stability: It is stable
Conditions to Avoid: Heat, humidity, Dust generation.
Incompatibility (Materials to Avoid): Strong oxidizing and reducing agents, Strong acids and bases.
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides.
Hazardous Polymerization: Will not occur
11. TOXICITY DATA
Acute toxicity: No data available
Carcinogenicity: This product present at levels greater than or equal to 0.1% is identified as probable, possible or confirmed human carcinogen by IARC, NTP, ACGIH & OSHA.
Mutagenic Effects: Not available.
Developmental Toxicity: Not available.
Reproductive Effects: No information available.
12. ECOLOGICAL DATA
Toxicity to fish: No data available
Bioaccumulative potential: Does not bioaccumulate.
This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher.
13. DISPOSAL INFORMATION
Waste Disposal Methods: Dispose in accordance with all applicable Federal, State and Local regulations.
14. TRANSPORT INFORMATION
DOT USA & ADR/RID Europe: Not regulated.
IMDG: Not regulated.
IATA: Not regulated.
15. REGULATORY INFORMATION
USA:16. ADDITIONAL INFORMATION
Section 355 (extremely hazardous substances): Substance is not listed.
Section 313 (Specific toxic chemical listings): Substance is not listed.
TSCA (Toxic Substances Control Act): Substance is listed.
Chemicals known to cause cancer: Substance is not listed.
Chemicals known to cause reproductive toxicity for females: Substance is not listed.
Chemicals known to cause reproductive toxicity for males: Substance is not listed.
Chemicals known to cause developmental toxicity: Substance is not listed.
Our company provides this MSDS sheet in good faith but makes no representation as to its comprehensiveness or accuracy. This SDS sheet is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product. The above information has been compiled from various sources and has the possibility of discrepancy and being out-dated information. Individuals receiving the information must exercise their independent judgment and do further search in determining its appropriateness for a particular purpose. In no case shall our company be liable to loss or damages by the product user.