Product name:

Sulfasalazine

Batch No.:

20230120

Mfg. Date:

Jan.20,2023

Exp. Date:

Jan.19,2027

Report Date:

Jan.21,2023

Quantity:

1000kgs

Execute standard：USP40

NO.

Item

Specification

Result

 1．

Appearance

Bright yellow or brownish-yellow,

Odorless,fine powder

Confirm

 2．

Identification

Conform With monograph A.B

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 3．

Solubility

Soluble in aqueous solutions of alkali hydroxides;very slightly soluble in alcohol;practically insoluble in water,in ether,in chloform,and in benzene

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4．

Chromatographic

purity

Single impurity  NMT2.0%

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Total impurity   NMT4.0%

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5．

Residual solvents

Pyridine  NMT200ppm

No detected

Toluene  NMT890ppm

No detected

DMF    NMT880ppm

No detected

6．

Mesh number

All through 80

Confirm

7．

Bulk density

---

0.38g/cc

8．

Tapped density

---

0.63g/cc

9．

Melting point

248-253℃

    250.0-252.5℃

10．

Chloride

NMT 0.014%

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11.

Sulphate

NMT 0.04%

Confirm

12.

Heavy metals

NMT 0.002%

Confirm

13.

Loss on drying

NMT 1.0%

0.51%

14.

Residue on ignition

NMT 0.5%

0.12%

15.

Assay

97.0—101.5%

99.12%

Conclusion: 

Comply with specification