Calcium Gluconate Anhydrous Monohydrate USP EP BP Ph Eur IP Pure AR LR Analytical Reagent FCC Food Grade Manufacturers, with SDS MSDS Sheet

Supplier, Manufacturer, Exporter of Calcium Gluconate USP EP BP Ph Eur IP Pure AR LR Analytical Reagent FCC Food Grade, 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, Peru, Argentina, Dubai, Korea, Vietnam, Thailand, Malaysia, Indonesia, Australia, China, Germany, France, Italy, Portugal, Bangladesh, etc.

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Calcium Gluconate CAS Number 299-28-5 for Anhydrous or 18016-24-5 for Monohydrate, EINECS EC Number 206-075-8, HS Code ---**; Molecular Weight 430.37, Molecular Formula: C12H22CaO14 (It has a monohydrate version apart from anhydrous grade)

Specifications, Safety Data Sheet, Manufacturing process details, Wholesale retail prices, Uses etc available on these pages for Calcium Gluconate Monohydrate Anhydrous.

Calcium gluconate is a mineral supplement. It is manufactured by the neutralization of gluconic acid with lime or calcium carbonate. It is an effective non-toxic calcium supplement.

Calcium Gluconate USP Grade Specifications
C12H22CaO14 (anhydrous) 430.37
D-Gluconic acid, calcium salt (2:1).
Calcium D-gluconate (1:2) [CAS 299-28-5].
Monohydrate 448.39

Calcium Gluconate is anhydrous or contains one molecule of water of hydration. The anhydrous form contains not less than 98.0 percent and not more than 102.0 percent of C12H22CaO14, calculated on the dried basis. The monohydrate form contains not less than 99.0 percent and not more than 101.0 percent of C12H22CaO14H2O where labeled as intended for use in preparing injectable dosage forms, and not less than 98.5 percent and not more than 102.0 percent of C12H22CaO14H2O where not intended for use in
preparing injectable dosage forms.

Identification:
A: A solution (1 in 50) responds to the test for Calcium.
B: Chromatographic plate test.
Loss on drying: Dry it at 105 for 16 hours: the anhydrous form loses not more than 3.0% of its weight; the monohydrate form, where labeled as intended for use in preparing injectable dosage forms, loses not more than 1.0% of its weight, and where not intended for use in preparing injectable dosage forms loses not more than 2.0% of its weight.
Chloride: A 1.0-g portion shows no more chloride than corresponds to 0.07 mL of 0.020 N hydrochloric acid (0.005%). Where it is not intended for use in the preparation of injectable dosage forms, a 1.0-g portion shows no more chloride than corresponds to 1 mL of 0.020 N hydrochloric acid (0.07%).
Limit of oxalate: Calcium Gluconate not intended for use in the preparation of injectable dosage forms is exempt from this requirement. For details please see the original monograph.
Limit of phosphate: To pass the test.
Sulfate: To pass the test.
Arsenic: The limit is 3 ppm.
Heavy metals: 0.001%. [Where Calcium Gluconate not intended for use in the preparation of injectable dosage forms, the limit is 0.002%.]
Limit of magnesium and alkali metals: (0.4%). [NOTE—Calcium Gluconate not intended for use in preparing injectable dosage forms is exempt from this requirement.]
Limit of iron: The limit is 5 ppm. [NOTE—Calcium Gluconate labeled as not intended for use in the preparation of injectable dosage forms is exempt from this requirement.]
Reducing substances: the limit is 1.0%.

Calcium Gluconate BP Grade Ph Eur Specifications
C12H22CaO14-H2O --- 448.4 --- CAS 18016-24-5

DEFINITION
Calcium D-gluconate monohydrate.
Content: 98.5 per cent to 102.0 per cent of C12H22CaO14,H2O.

CHARACTERS
Appearance: White or almost white, crystalline or granular powder.
Solubility: Sparingly soluble in water, freely soluble in boiling water.

IDENTIFICATION
A. Thin-layer chromatography.
B. Solution S (see Tests) gives the reactions of calcium.

TESTS
Solution S: Dissolve 1.0 g in water R heated to 60 °C and dilute to 50 ml with the same solvent.
Appearance of solution: At 60C, solution S is not more intensely coloured than reference solution. After cooling, it is not more opalescent than reference suspension.
Organic impurities and boric acid: To pass the test.
Sucrose and reducing sugars: To pass the test.
Chlorides: Maximum 200 ppm.
Sulphates: Maximum 100 ppm.
Magnesium and alkali metals: Maximum 0.4 per cent.
Heavy metals: Maximum 10 ppm.
Microbial contamination: Total viable aerobic count not more than 103 micro-organisms per gram, determined by plate count.

Calcium Gluconate FCC Food Grade Specifications
CH2OH(CHOH)4COO 2Ca
C12H22CaO14 Formula weight, anhydrous 430.38
C12H22CaO14-H2O Formula weight, monohydrate 448.39
CAS anhydrous 299-28-5
INS: 578

DESCRIPTION
Calcium Gluconate occurs as white, crystalline granules or powder. It is anhydrous or contains one molecule of water of hydration. It is stable in air. One gram dissolves slowly in about 30 mL of water at 25° and in about 5 mL of boiling water. It is insoluble in alcohol and in many other organic solvents. Its solutions are neutral to litmus.

REQUIREMENTS
Identification:
A. A 1:50 aqueous solution gives positive tests for Calcium.
B. Chromatographic test.
Assay: Anhydrous: Not less than 98.0% and not more than 102.0% of C12H22CaO14, calculated on the dried basis; Monohydrate: Not less than 98.0% and not more than 102.0% of
C12H22CaO14·H2O, calculated on the as-is basis.
Lead: Not more than 2 mg/kg.
Loss on Drying: Anhydrous: Not more than 3.0%; Monohydrate: Not more than 2.0%.
Sucrose and Reducing Sugars: Not more than 1.0%.

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.

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Calcium Gluconate SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 05-Oct-20

Product Name & Other Names: Calcium Gluconate; 2,3,4,5,6-Pentahydroxycaproic Acid hemi-calcium salt, Gluconic acid hemi-calcium salt, Calcium D-gluconate
CAS Number: monohydrate 18016-24-5; anhydrous 299-28-5
EINECS EC Code: 206-075-8
Chemical Formula: C12H22CaO14-H2O for monohydrate; C12H22CaO14 for anhydrous.
Molecular Weight: 448.39 for monohydrate; 430.37 for anhydrous
Relevant uses and uses advised against (if any): Industrial Manufacturing
Supplier: As per letterhead.

Section 2: Hazards Identification
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.

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

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.
Notes to Physician: Treat symptomatically.

Flammability of the Product: Non-flammable.
Auto-Ignition Temperature: Not applicable.
Flash Points: Not applicable.
Flammable Limits: Not applicable.
Products of Combustion: Calcium oxide, Fumes and Oxides of carbon.
Fire Fighting Media and Instructions: Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.
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. Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g. sand, earth, diatomaceous earth, vermiculite). 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.

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: Solid white to off-white powder or granules.
Odor: Odorless.
Odor threshold: Not available.
pH: 6 to 7
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 : 100C
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: Soluble in cold water.
Viscosity: Not available.
Chemical Formula: C12H22CaO14-H2O for monohydrate; C12H22CaO14 for anhydrous.
Molecular Weight: 448.39 for monohydrate; 430.37 for anhydrous.

Stability: It is stable.
Conditions of instability: Incompatible materials
Incompatibility with various substances: Heat, light, strong oxidizing agents, bases, amines, reducing agents, acids, acid anhydrides.
Polymerization: Will not occur.

Toxicity to Animals: LD50 Intravenous - rat - 950 mg/kg.
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.

Ecotoxicity: The product is not considered harmful to aquatic organisms or to cause long-term adverse effects in the environment. Not dangerous for the ozone layer.
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 & ADR/RID: Not dangerous goods
IMDG: Not dangerous goods
IATA: Not dangerous goods.

USA Regulations:
SARA 302: No chemicals in this material are subject to the reporting requirements of SARA Title III, Section 302.
SARA 313: This material does not contain any chemical components with known CAS numbers that exceed the threshold (De Minimis) reporting levels established by SARA Title III, Section 313.
SARA 311/312 Hazards: No SARA Hazards
California Prop. 65 Components: This product does not contain any chemicals known to State of California to cause cancer, birth defects, or any other reproductive harm.

DISCLAIMER: The information and recommendations set forth herein (hereinafter "Information") are presented in good faith and believed correct as of the date hereof. It is compiled from various sources and it is not necessarily all inclusive nor fully adequate in every circumstance. In addition, these suggestions should not be confused with nor followed in violation of applicable laws, regulations, rules or insurance requirements applicable. This MSDS sheet is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product. Individuals receiving the information must exercise their independent judgment in determining its appropriateness for a particular purpose.