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Product Detail
Product name
MANNITOL
Specifications
Pharmaceutical
Test According To
USP
Test date
09/07/2022
Batch NO.
J362207005
Quantity(kg)
10000
Packing Size
25kg/drum
Production Date
03/07/2022
Valid Date
02/07/2025
Pharmaceutical Excipients
Item
Unit
Standard/Spec.
Result
Characters
—
White crystalline powder，odorless
Pass
Identification
Be consistent with the refer
Clarity&colour
Clear and colorless
Loss on drying
%
≤0.5
0.05
Nickel
ppm
≤1.0
None(LOD=0.036)
Sorbitol
≤2.0
0.04
Maltitol and Isomalt
0.016
Unspecified impurities
≤0.1
0.072
Total impurities
≤2
0.12
Assay
97.0-102.0
99.9
Melting point
°C
165-170
166.5-167.5
Reducing sugar
<0.1
Conductivity
Us/cm
≤20
1.5
Total aerobic bacteria
CFU/g
≤103
10
Moulds and Yeasts
≤102
Escherichia coil
negative
Inspectian
Conclusion
This product is inspected according to the
USP standard.
Seal for Inspection Report (Seal)
Date of issuance: 10/07/2022
Date of issuance (Issue date): 10/07/2022
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