CHONDROITIN SULFATE SODIUM

ANALYTICAL METHODS

TESTS

Appearance Page 2
Identification Page 2
Clarity and Color of Solurion Page 2
pH Page 2
Loss on Drying Page 2
Residue on Ignition Page 2
Chloride Page 2

Sulfate Page 3

Heavy metals Page 3

Electrophoretic purity Page 3

Microbial Enumeration Page 3

Limit of Protein Page 3

Content of Chondroitin Sulfate Sodium Page 3

Date: February, 2017

Gnosis S.p.A. Via Lavoratori Autobianchi 1, 20832 Desio (MB) – Italy

1. APPEARANCE

Examine visually a sample of product against a white surface.

2. IDENTIFICATION (USP Monograph)

- IR: Complies with test A (Infrared absorption <197K>);

- Sodium: Complies with test B (Identification tests-General <191>, Sodium);
- Specific Optical Rotation: Complies with test D (Specific rotation <781S>).

Acceptance criteria for Specific Rotation: -2° to -12° d.b.

3. CLARITY AND COLOR OF SOLUTION (USP Monograph)

Complies with “Clarity and Color of Solution” section of the USP monograph.

4. PH (USP Monograph)

Complies with “pH <791>” section of USP Monograph.

5. LOSS ON DRYING (USP Monograph)

Complies with “Loss on Drying <731>” section of USP Monograph.

Acceptance criteria: NMT 10.0 %.

6. RESIDUE ON IGNITION (USP Monograph)

Complies with “Residue on Ignition <281>” section of USP Monograph.

7. CHLORIDE (USP Monograph)

Complies with “Chloride and Sulfate <221>, Chloride” section of USP Monograph.

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8. SULFATE (USP Monograph)

Complies with “Chloride and Sulfate <221>, Sulfate” section of USP Monograph.

9. HEAVY METAL (USP Monograph)

Complies with “Heavy Metals, Method II <231>” section of USP Monograph.

10. ELECTROPHORETIC PURITY (USP Monograph)

Complies with “Electrophoretic Purity” section of USP Monograph.

11. MICROBIAL ENUMERATION (USP Monograph)

Complies with “Microbial Enumeration Tests <2021>” section of USP Monograph.

Complies with “Absence of Specified Microorganism <2022>” section of USP Monograph.

12. LIMIT OF PROTEIN (USP Monograph)

Complies with “Limit of Protein” section of USP Monograph. Properly correct for a factor of 12 the weight of the
sample in order to fit the in-house acceptance criteria (see below Sample Solution preparation).

Sample Solution: Transfer a portion of Chondroitin Sulfate Sodium, equivalent to 720 mg of the dried substance to
a 100 ml volumetric flask, and dissolve in and dilute with water to volume.

Acceptance criteria: NMT 0.5 % d.b.

13. CONTENT OF CHONDROITIN SULFATE SODIUM (USP Monograph)

Complies with “Content of Chondroitin Sulfate Sodium” section of USP Monograph.

Reference Standard: Use Gnosis “Working Standard of Chondroitin Sulfate Sodium” 9-079.

Acceptance criteria: 95.0 % - 105.0 % d.b.