Product Name

:CITRIC ACID MONOHYDRATE

C.A.S. No.

:5949-29-1

Molecular Formula

: C₆H₈O₇H₂O

Molecular Weight

: 210.14

SPECIFICATION

IP

BP

USP

Description

Colorless crystals or a white crystalline powder, slightly efflorescent warm, dry air.

White or almost white, crystalline powder, colorless crystals or granules efflorescent.

White Powder

Solubility

-

Very soluble in water, freely soluble in ethanol (96 %).

-

Clarity of Solution

-

-

The Test solution shows the same clarity as that of water.

Appearance of solution (color)

20 % w/v solution is clear and not more intensely colored than reference solution YS7,BYS7 OR GYS7.

20 % w/v solution is clear and color less or not more intensely colored than reference solution Y7, BY7 and GY7.

The test solution is not more intensely colored than standard solution A,B, or C, or Water.

Identification

• (A) Reaction
• (B)) By IR Absorption
• (C) Reaction
• (D) Reaction
• (E) Test of water

• A 10 % w/v solution is strongly acidic.
• Reactions of citrates

• 10 % w/v solution is strongly acidic
• Must comply with the Citric acid anhydrous CRS.
• A red color develops
• White precipitate is produced
• Complies with the test of water.

By IR Spectrum

Arsenic

NMT 1ppm.

-

-

Bacterial end toxins

-

-

The level of bacterial endotoxins is such that the requirement in the relevant dosage form monograph(S) in which citric acid monohydrate is used can be met.

Barium

Any opalescence in the solution is not more intense than that in a mixture of 5 ml of solution and 5 ml of distilled water.

-

-

Sterility

-

-

Meets the requirements for sterility.

Calcium

NMT 200 ppm

-

-

Heavy metals

NMT 10 ppm

NMT 10 ppm

Iron

NMT 50 ppm

-

-

Readily carbonisable substance

Any color produced is not more than intense than that of the a mixture of 0.6 ml of CCS and 5.4 ml of FCS.

The solution is not more intensely colored than a mixture of 1 ml of red primary solution and 9 ml of yellow primary solution.

Any turbidity produced in test solution after 5 minutes standing is not greater than that produced in the standard solution (NMT 150 PPM)

Sulphates

NMT 150 ppm

NMT 150 ppm

NMT 150 ppm

Oxalic acid

Any pink color is produced is not more instance than that produced by carrying out the test using 0.2 ml of oxalic acid dissolve in 4 ml of water.

NMT 360 ppm

NMT 360 ppm

Limit of Aluminum

-

NMT 0.2 ppm

The fluorescencence of the test solution does not exceed that of the standard solution (0.2 µg/g)

Residual Solvents

-

-

Meets the requirements

Chlorides

NMT 50 ppm

-

-

Water by KF

7.5% - 9.0%

7.5 % - 9.0 %

7.5% - 9.0 %

Sulphated ash

NMT 0.1 %

NMT 0.1 %

NMT 0.1 %

Assay

99.0 % to 101.0 %

99.5 % - 100.5 %

99.5 % - 100.5 %