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Cyanocobalamin

CAS No.: 68-19-9
Molecular Weight: 1355.37 g/mol
Chemical Formula C63H88CoN14O14P

Cyanocobalamin is a form of vitamin B12 used to treat vitamin B12 deficiency. It is used in pharmaceutical industry and in supplements.

General Properties and Specifications of Cyanocobalamin or 5,6-Dimethylbenzimidazolyl cyanocobamide or Vitamin B12:
Appearance: Dark red powder or crystals.
Odor: Odorless.
Assay on dried basis: 96% to 102% minimum.
Loss on drying: 12% maximum.
Melting point: >300C.
Solubility: Slightly soluble in water.
Storage: 2C to 8C.

Cyanocobalamin USP Grade Specifications:
C63H88CoN14O14P -- 1355.37
Vitamin B12 --- CAS 68-19-9
UNII: P6YC3EG204

DEFINITION
Cyanocobalamin contains NLT 96.0% and NMT 102.0% of cyanocobalamin (C63H88CoN14O14P), calculated on the dried basis.

IDENTIFICATION
A. Ultraviolet Absorption: To pass the test.
B.
Sample solution: Fuse 1 mg of Cyanocobalamin with 50 mg of potassium pyrosulfate in a porcelain crucible. Cool, break up the mass with a glass rod, add 3 mL of water, and dissolve by boiling.
Analysis: Add 1 drop of phenolphthalein and add sodium hydroxide solution (100 mg/mL), dropwise, until just pink. Add 500 mg of sodium acetate, 0.5 mL of 1 N acetic acid, and 0.5 mL of nitroso salt solution (2 mg/mL). Add 0.5 mL of hydrochloric acid, and boil for 1 min.
Acceptance criteria: A red or orange-red color appears immediately after the addition of nitroso salt. The red color persists after boiling with the addition of hydrochloric acid.
C. HPLC: To pass the test.

Related Compounds: To pass the test by Chromatography.
Loss on Drying:
Sample: 25 mg.
Analysis: Dry the Sample in a suitable vacuum drying apparatus at 105C and at a pressure of NMT 5 mm of mercury for 2 h.
Acceptance criteria: NMT 12.0%
Packaging and Storage: Preserve in tight, light-resistant containers, and store at controlled room temperature.


Cyanocobalamin BP Ph Eur Grade Specifications:
C63H88CoN14O14P – 1355 – CAS 68-19-9
Action and use: Vitamin B12 analogue.

IDEFINITION
α-(5,6-Dimethylbenzimidazol-1-yl)cobamide cyanide.
Content: 96.0 per cent to 102.0 per cent (dried substance).

CHARACTERS
Appearance: Dark red, crystalline powder or dark red crystals.
Solubility: Sparingly soluble in water and in ethanol (96 per cent), practically insoluble in acetone.
The anhydrous substance is very hygroscopic.

IDENTIFICATION
A. Ultraviolet and visible absorption spectrophotometry: To pass the test.
B. Thin-layer chromatography: To pass the test.
Related substances: To pass the test by Liquid chromatography.
Loss on drying: Maximum 12.0 per cent, determined on 40.00 mg by drying in vacuo at 105C for 2 h.

STORAGE
In an airtight container, protected from light.


Vitamin B12 FCC Food Grade
Cyanocobalamin FCC Food Grade Specifications
:
C63H88CoN14O14P Formula weight --- 1355.38
CAS 68-19-9

DESCRIPTION
Vitamin B12 occurs as dark red crystals or as an amorphous or crystalline powder. In the anhydrous form, it is very hygroscopic, and when exposed to air, it may absorb about 12% of water. It is sparingly soluble in water; soluble in alcohol; and insoluble in acetone, in chloroform, and in ether.
Function: Nutrient.

REQUIREMENTS
Identification:
A. The absorption spectrum of the Sample Solution used to measure absorbance in the Assay (below) exhibits maxima within _1 nm at 278 nm and 361 nm, and within _2 nm at 550 nm. The ratio A361/A278 is between 1.70 and 1.90, and the ratio A361/A550 is between 3.15 and 3.40.
B. Fuse about 1 mg of sample with about 50 mg of potassium pyrosulfate in a porcelain crucible, cool, and break up the mass with a glass rod. Add 3 mL of water, and dissolve by boiling. Add 1 drop of phenolphthalein, mix, and then add drops of a 1:10 solution of sodium hydroxide until just pink. Add 500 mg of sodium acetate, 0.5 mL of 1 N acetic acid, and 0.5 mL of a 1:500 solution of nitroso salt. A red or orange-red color appears at once. Add 0.5 mL of hydrochloric acid, and boil for 1 min. The red color persists.
C. Dissolve about 5 mg of sample in 5 mL of water contained in a 50-mL distilling flask connected to a short, watercooled, vertical condenser, the tip of which dips into a test tube containing 1 mL of a 1:50 solution of sodium hydroxide. Add 2.5 mL of hypophosphorous acid to the flask, then close the flask, heat at simmering for 10 min, and distill 1 mL into the test tube. Add 4 drops of cold, saturated ferrous ammonium sulfate solution to the tube, shake gently, then add about 30 mg of sodium fluoride, and bring the contents to a boil. Immediately add drops of 1:7 sulfuric acid until a clear solution results, and then add 3 to 5 drops more of the acid. A blue or blue-green color appears within a few minutes.
Assay: Not less than 96.0% and not more than 100.5% of C63H88CoN14O14P, calculated on the dried basis.
Loss on Drying: Not more than 12.0%.
Pseudo Cyanocobalamin: Passes test.