API(active pharmaceutical ingredient)

  • Menthol Crystal

Menthol Crystal

Certificate of Analysis

Menthol Crystal

Manufacture Date

29    NOV. , 2016

Batch/Lot  No.:

     1611279

Expiry   Date

28    NOV. , 2019

Package   (N.W)

25kgs/drum

Quality   Criterion

B P2005 / USP32 / GB3862-2006

Quantity

  10000kgs 

Testing   Report

Testing   Items

Quality Criterion

Testing Result

Color And   Appearance

Colorless, Transparent Hexagonal

Or Needlelike Crystals

Conform

Odor

Have the characteristic odor of

Chinese natural menthol

Conform

Identification

Shall   comply with the USP requirement

Conform

Melting   Point

41.5℃44℃

41.55℃-42.6℃

Solubility25℃

Melting 1 gram test sample into 5ml 90% alcohol

Conform

Non -   Volatile Content

≤ 0.05%

0.0180%

Organic volatile impurities

Shall   comply with the USP requirement

Conform

Specific   Rotation25

- 50° -   49°

-49.50°

Arsenic   Content mg/kg

≤ 3

<3

Heavy   Metal, as Pbmg/kg

≤ 10

<10

Purity

≥ 99.5%

99.51%

Microbiological   Contamination/g

A)       Total   aerobic microbial count

B)       Total   conbined moulds & yeasts

C)      Other   specific micro organisms(E.Coli, Salmonella sp)

 

1000   cfu

100   cfu

Absent in 1g

Testing Results

As   Standard of B P2005 /   USP32 /   GB3862-2006

Conform

Storage   Condition

Dry And Cool Place Below 25℃, Away   From Heating Or Ignition; Avoid Direct Shining; Must Re-Inspect Each Half   Year.


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