Product Name

Retinoic acid (tretinoin)

Batch No.

240820

MFG. Date

2024.08.20

Exp. Date

2024.08.20

QTY

15kg

Standard

USP34

ITEMS

SPECIFICATIONS

RESULTS

Description

Yellow to light-orange crystalline powder

Yellow crystalline powder

Identification :A

            B

UV

IR

Complies

Complies

Solubility

Insoluble in water,slightly soluble inalcohol and in chloroform

Complies 

Loss on drying

Not more than 0.5%

0.04%

Residue on ignition

Not more than 0.1%

0.03%

Heavy metals

Not more than 0.002%

＜0.002%

Limit of isotretinoin

Not more than 5.0%

0.56%

Particle size

99% less than 20um

Complies

Organic volatile impurities

Meet the requirements

Complies

Assay

98.0～102%(Calculated on the dried basis)

99.9%

Conclusion

Test results conform with USP34