Croscarmellose Sodium or Sodium Croscarmellose USP NF BP Ph Eur JP EP IP Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Croscarmellose Sodium USP NF BP Ph Eur JP EP IPMuby 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, Bangladesh, etc.

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Croscarmellose Sodium or Sodium Croscarmellose: CAS Number: 74811-65-7, EINECS EC Number: 1312995-182-4, Molecular Formula: yy, Molecular Weight: yy, HS Code ---**

Specifications, Safety Data Sheet, Manufacturing process details, Wholesale retail buy sell prices, Uses etc available on line in these pages for Croscarmellose Sodium or Sodium Croscarmellose.

Croscarmellose or sodium Sodium croscarmellose is an internally cross-linked sodium carboxymethylcellulose for use as a superdisintegrant in pharmaceutical formulations and other uses. Croscarmellose sodium, or sodium CMC, is a cross-linked polymer of carboxymethylcellulose sodium. It appears as white, fibrous, free-flowing powder, and is used commonly as an FDA-approved disintegrant in pharmaceutical manufacturing. E468 is the E number of crosslinked sodium carboxymethyl cellulose, used in food as an emulsifier. The cross-linking reduces water solubility while still allowing the material to swell (like a sponge) and absorb many times its weight in water. As a result, it provides superior drug dissolution and disintegration characteristics, thus improving formulas' subsequent bioavailability by bringing the active ingredients into better contact with bodily fluids.

General Properties and Specifications of Sodium Croscarmellose or Croscarmellose Sodium:
Appearance: White, fibrous, free-flowing powder.
Odor: Oderless.
pH: 5.0 ~ 7.0
Loss on drying: NMT 10.0%
Na-chloride & Na-glucolate: NMT 0.5%
Heavy metals: NMT 10ppm
Water-soluble substances: NMT 10.0%.

DEFINITION
Croscarmellose Sodium is the sodium salt of a cross-linked, partly O-(carboxymethylated) cellulose.

IDENTIFICATION
A. Mix 1 g with 100 mL of methylene blue solution (1 in 250,000), stir the mixture, and allow it to settle. The Croscarmellose Sodium absorbs the methylene blue and settles as a blue, fibrous mass.
B. Mix 1 g with 50 mL of water. Transfer 1 mL of the mixture to a small test-tube and add 1 mL of water and 5 drops of 1-naphthol TS. Incline the test tube, and carefully add 2 mL of sulfuric acid down the side so that it forms a lower layer: a reddish-violet color develops at the interface.

Residue on Ignition: 14.0%–28.0%, calculated on the dried basis. Use 1.0 g for the test and use sufficient sulfuric acid to moisten the entire residue after the initial charring step, and additional sulfuric acid if an excessive amount of carbonaceous material remains after the initial complete volatilization of white fumes.
Sodium Chloride and Sodium Glycolate: To pass the test.
Acceptance criteria: The sum of the percentages of sodium chloride and sodium glycolate is NMT 0.5%.
Content of Water-Soluble Material: To pass the test.
Acceptance criteria: NMT 10.0%.
Degree of Substitution: To pass the test.
Acceptance criteria: The degree of substitution is 0.60–0.85 on the dried basis.
Loss on Drying: Dry at 105C for 6 h.
Acceptance criteria: NMT 10.0%
Microbial Enumeration Tests and Tests for Specified Microorganisms: The total aerobic microbial count does not exceed 1000 cfu/g, and the total combined molds and yeasts count does not exceed 100 cfu/g. It meets the requirements of the test for absence of Escherichia coli.
pH: Mix 1 g with 100 mL of water for 5 min.
Acceptance criteria: 5.0–7.0
Settling Volume: To pass the test.
Acceptance criteria: The volume of the settled mass is 10.0–30.0 mL.
Packaging and Storage: Preserve in well-closed containers. No storage requirements specified.

Specifications of Croscarmellose Sodium BP Ph Eur:
Action and use: Excipient.

DEFINITION
Cross-linked sodium carboxymethylcellulose.
Sodium salt of a cross-linked, partly O-carboxymethylated cellulose.

CHARACTERS
Appearance: White or greyish-white, hygroscopic powder.
Solubility: Practically insoluble in acetone, in anhydrous ethanol and in toluene.

IDENTIFICATION
A. Mix 1 g with 100 mL of a solution containing 4 ppm of methylene blue, stir the mixture and allow it to settle. The substance to be examined absorbs the methylene blue and settles as a blue, fibrous mass.
B. Mix 1 g with 50 mL of water. Transfer 1 mL of the mixture to a small test-tube and add 1 mL of water and 0.05 mL of a freshly prepared 40 g/L solution of α-naphthol in methanol. Incline the test-tube and carefully add 2 mL of sulfuric acid down the side so that it forms a lower layer. A reddish-violet colour develops at the interface.
C. To the residue obtained in the test for sulfated ash add 1 mL of hydrochloric acid and evaporate on a water-bath. Take up the residue in 20 mL of water. The solution gives reaction of sodium.

TESTS
pH: 5.0 to 7.0 for the suspension.
Shake 1 g with 100 mL of carbon dioxide-free water for 5 min.
Sodium chloride and sodium glycollate: Maximum 0.5 per cent (dried substance) for the sum of the percentage contents of sodium chloride and sodium glycollate.
Water: soluble substances: Maximum 10.0 per cent.
Loss on drying: Maximum 10.0 per cent, determined on 1.000 g by drying in an oven at 105C for 6 h.
Sulfated ash: 14.0 per cent to 28.0 per cent (dried substance), determined on 1.0 g.
Microbial contamination:
TAMC: acceptance criterion 1000 CFU/g.
TYMC: acceptance criterion 100 CFU/g.
Absence of Escherichia coli.
Settling volume: Place 75 mL of water in a 100 mL graduated cylinder and add 1.5 g of the substance to be examined in 0.5 g portions, shaking vigorously after each addition. Dilute to 100.0 mL with water and shake again until the substance is homogeneously distributed. Allow to stand for 4 h. The settling volume is between 10.0 mL and 30.0 mL.
Degree of substitution: 0.60 to 0.85 (dried substance).

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Croscarmellose Sodium or Sodium Croscarmellose SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 11-Oct-20

Product Name & Other Names: Croscarmellose Sodium or Sodium Croscarmellose.
CAS Number: 74811-65-7
EINECS EC Code: 1312995-182-4
Relevant uses and uses advised against (if any): Industrial use.
Recommended usage: Industrial Manufacturing.
Suppliers: As per letterhead.

Section 2: Hazards 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.

Hazards not otherwise classified (HNOC):
May causes mild skin irritation.
May causes mild eye irritation.

Precautionary statements:
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.

Product Name & Other Names: Croscarmellose Sodium or Sodium Croscarmellose.
CAS Number: 74811-65-7
EINECS EC Code: 1312995-182-4

Skin: Rinse with water. Soap may be used. Seek Medical Aid.
Eyes: Wash eyes with plenty of water for at least 15 minutes, lifting lids occasionally. Seek Medical Aid.
Inhalation: Remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen.
Ingestion: If swallowed, induce vomiting immediately after giving two glasses of water. Never give anything by mouth to an unconscious person.

Flammability of the Product: Non-flammable.
Products of Combustion: Oxides of Carbon and Sodium.
Fire Fighting Media and Instructions: Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide. Wear self-contained breathing apparatus for firefighting if necessary.
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.

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:
Small Spill: Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and dispose of according to legal requirements.
Large Spill: Do not inhale vapors, mist, or gas. Avoid dust formation. Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and allow to evacuate as per law.

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 in cool, 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 oxidizing agents, acids.

Occupational exposure limits: No exposure limits known for ingredient.
Engineering Controls: 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 below the exposure limit.
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.

Physical state and appearance: White, fibrous, free-flowing powder.
Odor: Odorless.
Odor threshold: Not available.
pH: 5.0 ~ 7.0
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: Slightly soluble in water.
Viscosity: Not available.

Stability: It is stable in room temperature in closed containers under normal storage & handling. In fine distribution, when whirled up a dust explosion potential may be assumed.
Conditions of instability: Incompatible materials, Moisture
Incompatibility with various substances: Avoid high temperatures, sparks, open flames and moisture. Avoid contact with strong oxidizing agents and acids.
Polymerization: Will not occur.

Acute toxicity: No information available.
Carcinogenic Effects: Not a reported carcinogen by IARC, NTP, ACGIH, OSHA.
Mutagenic Effects: Not available.
Developmental Toxicity: Not available.
Reproductive Effects: No information available.

Toxicity to fish: No information available.
Persistence and Degradability: No information available.
Mobility: No information available.
Bioaccumulation/ Accumulation: No information available.
Results of PBT and vPvB assessment: No data available for assessment.

Waste Disposal: Waste must be disposed of in accordance with federal, state and local environmental control regulations.

DOT USA: Not dangerous goods
IMDG: Not dangerous goods
IATA: Not dangerous goods
ADR/RID Europe: Not dangerous goods

USA Regulations:
OSHA: None of the chemicals in this product are considered highly hazardous by OSHA.
SARA 313: Not applicable
SARA 311/312 Hazardous Categorization: Not applicable.
California Proposition 65: This product does not contain any Proposition 65 chemicals.

Disclaimer:
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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.
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