Specifications, Uses, SDS of Sodium Starch Glycolate Manufacturers

	King of Chemicals Manufacturers
Specifications, Properties, Uses, SDS of Sodium Starch Glycolate USP NF BP Ph Eur Grade Type A B C Manufacturer Supplier Exporter Wholesale & Small Packs, CAS Number 9063-38-1.
King of Chemicals has several associated companies having accreditations like cGMP, GLP - FDA Approved Good Manufacturing Practice and Good Laboratory Practice of WHO standard, ISO-9001, ISO-14001, ISO/IEC 17025, ISO ISO-45000, HACCP, FSSC 220000, FSSAI, "REACH" Registered, Kosher & Halal Certified. e-CTD and DMF support can be made available if needed. We offer USP NF BP Ph Eur EP IP JP Analytical Reagent FCC Food Grade Chemicals & Nutraceuticals.

Muby Chem Pvt. Ltd. is a several decades old group of companies, engaged in manufacturing, supplying, distributing, wholesale supplies of Sodium Starch Glycolate Type A B C for actual users, including retail or small pack supplies for research and development work.

We supply fine and speciality chemicals, pharmaceutical excipients, mineral fortifiers in chemically pure, analytical reagent grade, IP BP USP Ph Eur EP JP and other pharmaceutical grade monograph including FCC Food grade chemicals and Nutraceuticals at best prices. We and/or our associated units have all the facilities to supply as per cGMP standard observing good manufacturing practice and good laboratory practice. We can assure low microbial count and also offer a test certificate for the same. We maintain warehouses across USA, India, and UAE. Our group exports to USA, Canada, Mexico, Argentina, Brazil, Chile, Korea, Malaysia, Thailand, Indonesia, Europe, and several other parts of the world. We supply in wholesale container loads to small pack of few grams. Solid products may be specified for it size and shape as desired by the buyer.

The Properties, Specifications, Monograph and Uses of Sodium Starch Glycolate:

Sodium starch glycolate is a commonly used super-disintegrant employed to promote rapid disintegration and dissolution of IR solid dosage forms. It is manufactured by chemical modification of starch, i.e., carboxymethylation to enhance hydrophilicity and cross-linking to reduce solubility. It absorbs water rapidly, resulting in swelling which leads to rapid disintegration of tablets and granules.

Sodium Starch Glycolate USP NF Grade Specifications:
Starch carboxymethyl ether, sodium salt.

DEFINITION
Sodium Starch Glycolate is the sodium salt of a carboxymethyl ether of starch or of a cross-linked carboxymethyl ether of starch. It may contain NMT 7.0% of Sodium Chloride. The pH and assay requirements for Type A and Type B are set forth in the accompanying table.

IDENTIFICATION
A. Infrared Absorption
B. An acidified solution of it is colored blue to violet by the addition of iodine and potassium iodide.
C.
Potassium pyroantimonate solution: Dissolve 2 g of potassium pyroantimonate in 85 mL of hot water. Cool quickly and add 10 mL of a solution of potassium hydroxide (3 in 20). Allow to stand for 24 h, filter, and dilute with water to 100 mL.
Analysis: To a 2-mL portion of the Sample solution prepared for the test for Limit of Iron, add 2 mL of 15% potassium carbonate, and heat to boiling. No precipitate is formed. Add 4 mL of Potassium pyroantimonate solution, and heat to boiling. Allow to cool in ice water and, if necessary, rub the inside of the test tube with a glass rod.
Acceptance criteria: A dense precipitate is formed.
D. Sodium Starch Glycolate imparts an intense yellow color to a nonluminous flame.

DEFINITION
Sodium salt of a cross-linked partly O-carboxymethylated potato starch.
Content: 2.8 per cent to 4.2 per cent of Na (A 22.99) (substance washed with ethanol (80 per cent V/V) and dried).

CHARACTERS
Appearance: White or almost white, fine, free-flowing powder, very hygroscopic.
Solubility: Practically insoluble in methylene chloride. It gives a translucent suspension in water.
Examined under a microscope it is seen to consist of: granules, irregularly shaped, ovoid or pear-shaped, 30-100 µm in size, or rounded, 10-35 µm in size; compound granules consisting of 2-4 components occur occasionally; the granules have an eccentric hilum and clearly visible concentric striations; between crossed nicol prisms, the granules show a distinct black cross intersecting at the hilum; small crystals are visible at the surface of the granules. The granules show considerable swelling in contact with water.

IDENTIFICATION
A. pH (see Tests).
B. Prepare with shaking and without heating a mixture of 4.0 g of the substance to be examined and 20 ml of carbon dioxide-free water. The mixture has the appearance of a gel. Add 100 ml of carbon dioxide-free water and shake. A suspension forms that settles after standing.
C. To an acidified solution, add iodinated potassium iodide solution. The solution becomes blue or violet.
D. Solution S2 (see Tests) gives reaction of sodium.

TESTS
Solution S1: Centrifuge the suspension obtained in identification test B at 2500 g for 10 min. Collect carefully the supernatant liquid.
Solution S2: Place 2.5 g in a silica or platinum crucible and add 2 ml of a 500 g/l solution of sulphuric acid. Heat on a water-bath, then cautiously over a naked flame, raising the temperature progressively, then incinerate in a muffle furnace at 600 ± 25C. Continue heating until all black particles have disappeared. Allow to cool, add a few drops of dilute sulphuric acid, heat and incinerate as above. Allow to cool, add a few drops of ammonium carbonate solution, evaporate to dryness and incinerate cautiously. Allow to cool and dissolve the residue in 50 ml of water.
Appearance of solution S1: Solution S1 is clear and colourless.
pH: 5.5 to 7.5. Disperse 1.0 g in 30 ml of water.
Sodium glycolate: Maximum 2.0 per cent. Carry out the test protected from light.
Sodium chloride: Maximum 7.0 per cent.
Iron: Maximum 20 ppm determined on 10 ml of solution S2.
Heavy metals: Maximum 20 ppm. 1.0 g complies with test D. Prepare the reference solution using 2 ml of lead standard solution (10 ppm Pb).
Loss on drying: Maximum 10.0 per cent, determined on 1.000 g by drying in an oven at 130C for 1.5 h.
Microbial contamination: It complies with the test for Escherichia coli and Salmonella.

DEFINITION
Sodium salt of a cross-linked partly O-carboxymethylated potato starch.
Content: 2.0 per cent to 3.4 per cent of Na (A 22.99) (substance washed with ethanol (80 per cent V/V) and dried).

CHARACTERS
Appearance: White or almost white, fine, free-flowing powder, very hygroscopic.
Solubility: Practically insoluble in methylene chloride. It gives a translucent suspension in water.
Examined under a microscope it is seen to consist of: granules, irregularly shaped, ovoid or pear shaped, 30-100 µm in size, or rounded, 10-35 µm in size; compound granules consisting of 2-4 components occur occasionally; the granules have an eccentric hilum and clearly visible concentric striations; between crossed nicol prisms, the granules show a distinct black cross intersecting at the hilum; small crystals are visible at the surface of the granules. The granules show considerable swelling in contact with water.

TESTS
Solution S1: Centrifuge the suspension obtained in identification test B at 2500 g for 10 min. Collect carefully the supernatant liquid.
Solution S2: Place 2.5 g in a silica or platinum crucible and add 2 ml of a 500 g/l solution of sulphuric acid. Heat on a water-bath, then cautiously over a naked flame, raising the temperature progressively, and then incinerate in a muffle furnace at 600 ± 25C. Continue heating until all black particles have disappeared. Allow to cool, add a few drops of dilute sulphuric acid and heat and incinerate as above. Allow to cool, add a few drops of ammonium carbonate solution, evaporate to dryness and incinerate cautiously. Allow to cool and dissolve the residue in 50 ml of water. Appearance of solution S1
Appearance of solution S1: Solution S1 is clear and colourless.
pH: 3.0 to 5.0. Disperse 1.0 g in 30 ml of water.
Sodium glycolate: Maximum 2.0 per cent. Carry out the test protected from light.
Sodium chloride: Maximum 7.0 per cent.
Iron: Maximum 20 ppm determined on 10 ml of solution S2.
Heavy metals: Maximum 20 ppm.
Loss on drying: Maximum 10.0 per cent, determined on 1.000 g by drying in an oven at 130C for 1.5 h.
Microbial contamination: It complies with the test for Escherichia coli and Salmonella.

DEFINITION
Sodium starch glycolate (type C) is the sodium salt of a cross-linked by physical dehydration, partly O-carboxymethylated starch. It contains not less than 2.8 per cent and not more than 5.0 per cent of Na (A 22.99), calculated with reference to the substance washed with alcohol (80 per cent V/V) and dried.

CHARACTERS
A white or almost white, fine, free-flowing powder, very hygroscopic, soluble in water, practically insoluble in methylene chloride. It gives a translucent gel-like product in water.
Examined under a microscope it is seen to consist of granules, irregularly shaped, ovoid or pear-shaped, 30 µm to 100 µm in size, or rounded, 10 µm to 35 µm in size; compound granules consisting of two to four components occur occasionally; the granules have an eccentric hilum and clearly visible concentric striations; between crossed nicol prisms, the granules show a distinct black cross intersecting at the hilum; small crystals are visible at the surface of the granules. The granules show considerable swelling in contact with water.

IDENTIFICATION
A. It complies with the test for pH (see Tests).
B. Mix with shaking and without heating 4.0 g and 20 ml of carbon dioxide-free water. The mixture has the appearance of a gel. Add 100 ml of carbon dioxide-free water and shake: the gel remains stable (difference from types A and B). Keep the gel for the tests for appearance of gel and pH.
C. To 5 ml of the gel obtained in identification test B add 0.05 ml of iodine solution. A dark blue colour is produced.
D. Solution S (see Tests) gives reaction of sodium.

TESTS
Solution S: Place 2.5 g in a silica or platinum crucible and add 2 ml of a 500 g/l solution of sulphuric acid. Heat on a water-bath, then cautiously over a naked flame, raising the temperature progressively, and then incinerate in a muffle furnace at 600 ± 25C. Continue heating until all black particles have disappeared. Allow to cool, add a few drops of sulphuric acid and heat and incinerate as described above. Allow to cool, add a few drops of ammonium carbonate solution, evaporate to dryness and incinerate cautiously. Allow to cool and dissolve the residue in 50 ml of water.
Appearance of gel: The gel prepared under identification test B is colourless.
pH: The pH of the gel prepared under identification test B is 5.5 to 7.5.
Sodium glycolate: Carry out the test protected from light. (2.0 per cent).
Sodium chloride: Not more than 1 per cent.
Iron: 10 ml of solution S complies with the limit test for iron (20 ppm).
Heavy metals: 1.0 g complies with limit test D for heavy metals (20 ppm).
Loss on drying: Not more than 7.0 per cent, determined on 1.000 g by drying in an oven at 100C to 105C for 4 h.
Microbial contamination: It complies with the test for Escherichia coli and Salmonell).

Sodium Starch Glycolate SDS, Safety Data Sheet
MSDS, Material Safety Data Sheet 22-Aug-21

Product Name & Other Names: Sodium Starch Glycolate.
CAS#: 9063-38-1
EINECS EC Number: 618-597-7
Chemical Formula: Not available.
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Suppliers: As per letterhead.

GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Classification according to Regulation (EC) No 1272/2008

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.

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.
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: Sodium Starch Glycolate.
CAS#: 9063-38-1
EINECS EC Number: 618-597-7

Eye Contact: Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. Get medical attention if irritation occurs.
Skin Contact: Wash with soap and water. Cover the irritated skin with an emollient. Get medical attention if irritation develops.
Inhalation: If Sodium Starch Glycolate is inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention.
Ingestion: Do Not induce vomiting unless directed to do so by medical personnel. If large quantities of this material are swallowed, call a physician immediately. Loosen tight clothing.

Flammability of the Product: Not classed as fire hazard but it may be combustible at high temperature.
Auto-Ignition Temperature: Not available.
Flash Points: Not available.
Flammable Limits: Not available.
Products of Combustion: Not available.
Explosion Hazards in Presence of Various Substances: Not available.
Fire Fighting Media and Instructions: Use DRY chemical powder, water spray, fog, or foam. Do not use solid water jet.
Extinguishing Media Not recommended: Avoid using solid water jet as it may scatter the fire.
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. Fire-extinguishing work is done from the windward and the suitable fire-extinguishing method according to the surrounding situation is used. Uninvolved persons should evacuate to a safe place.

Personal precautions, protective equipment, and emergency procedures: Avoid breathing dust/fumes/gas/mist/vapors/spray. 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: Do not inhale dust, vapors, mist, or gas. Avoid dust formation. Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g., sand, earth, diatomaceous earth, vermiculite). 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. In case of insufficient ventilation, wear suitable respiratory equipment. 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. 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 agents. Keep away from sources of ignition. Ground all equipment containing material.

Exposure Limits: This product does not contain any hazardous materials with occupational exposure limits established by the region-specific regulatory bodies. There is a blanket recommendation of 10 mg/m3 for inspirable dusts or mists when limits have not otherwise been established.
Engineering Controls: Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below recommended exposure limits.
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: Solid. White powder.
Odor: Odorless.
Odor threshold: Not available.
pH: Not available.
Relative density: around 0.95
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: Insoluble in cold water, hot water.
Viscosity: Not available.

Stability: Stable under normal usage and storage.
Incompatibility with various substances: Strong oxidizing agents.
Corrosivity: Not available.
Polymerization: Will not occur.

Toxicity to Animals: Not available.
Carcinogenicity: No component of this product present at levels greater than or equal to 0.1% is identified as possible or confirmed human carcinogen by IARC, ACGIH, OSHA and NTP.
Teratogenic Effects: Not available.
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.

Land Transport DOT USA, TDG Canada & ADR/RID Europe: Not regulated.
Air Transport IATA/ICAO: Not regulated.
Sea Transport IMDG/IMO: Not regulated.

USA Regulations:
California Proposition 65: Not listed.
SARA 311/312 Hazards: See section 2.

Sodium Starch Glycolate Manufacturers, Suppliers, Exporters, Wholesalers:

Plot No. 2900/46&47 + 2900/163to167, GIDC, Ankleshwar, Dist. Bharuch, India
India, USA, UAE
TEL: (Office) 91-22-23774610, 91-22-23723564

If I give you “My Word” Nobody can undo it.
If I sign an “Agreement” my Lawyer will undo it

Our products are for industrial and laboratory use only. The user must test the material before use. We are not dispensing chemists or druggist and do not offer over the counter type (OTC) products for medical use by individuals. Check.

	pH	% Sodium, Combined as Sodium Starch Glycolate
Type	Min. to Max.	Minimum to Maximum
A	5.5 to 7.5	2.8 to 4.2
B	3.0 to 5.0	2.0 to 3.4

Specifications, Properties, Uses, SDS of Sodium Starch Glycolate USP NF BP Ph Eur Grade Type A B C Manufacturer Supplier Exporter Wholesale & Small Packs, CAS Number 9063-38-1.

Sodium Starch Glycolate Manufacturers, Suppliers, Exporters, Wholesalers: