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Lactose Monohydrate CAS 10039-26-6 and Lactose Anhydrous 63-42-3 Food Grade or Pharmaceutical Grade
Product Name: |
Lactose Monohydrate |
Lactose Anhydrous |
Synonyms: |
Lactose Mono |
Lactose Anhydrate |
Grade Types: |
Food Grade & Pharmaceutical Grade |
|
Characteristics: |
White crystalline powder |
White crystalline powder |
CAS Number: |
10039-26-6 |
63-42-3 |
Assay: |
99% Min |
99% Min |
Formula: |
C12H24O12 |
C12H22O11 |
Structure: |
|
|
Package: |
25Kg/ Bag or Drum |
25Kg/ Bag or Drum |
Usage: Our Lactose Monohydrate and Lactose Anhydrous are for pharmaceutical excipient use. It is added to the drugs to make the drug taste good. Lactose Monohydrate and Lactose Anhydrous will make together with APIs like antibiotics or other nutrition materials. Normally, enzymes in your body break down lactose and absorb it into your bloodstream.
Certificate of Analysis: Lactose Monohydrate
Product |
Lactose Monohydrate |
|
Tests |
Specification |
|
|
Identification A
Identification B Identification C Specific rotation Acidity or alkalinity
Loss on drying Water Residue on ignition Heavy metals Protein & light-absorb impurities TPC (cfu/g) Yeast & Mould (cfu/g) Escherichia coli (/10g) |
The infrared absorption spectrum of the sample is concordant with that of the standard. Should comply A red color develops. +54.4°~+55.9°on the anhydrous basis. Add 0.3ml of phenolphthalein TS: the solution is colorless, and not more than 0.4 ml of 0.1 N sodium hydroxide is required to produce a red color. 1% Max 4.5%~5.5% 0.1% Max 5µg per g. Max Should comply
<100 <50 absence |
Complies
Complies Complies +54.9° Complies
0.08% 4.7% 0.05% <5µg / g Complies
< 10 < 10 Not detected |
Certificate of Analysis: Lactose Anhydrous
Product |
Lactose Anhydrous |
|
Tests |
Specification |
|
|
Identification A
Identification B Identification C Specific rotation Acidity or alkalinity
Water Residue on ignition Heavy metals Protein & light-absorb impurities TPC Yeast & Mould (cfu/g) Escherichia coli (/10g) |
The infrared absorption spectrum of the sample is concordant with that of the standard. Should comply A red color develops. +54.4°~+55.9°on the anhydrous basis. Add 0.3ml of phenolphthalein TS: the solution is colorless, and not more than 0.4 ml of 0.1 N sodium hydroxide is required to produce a red color. 1.0% Max 0.1% Max 5µg per g. Max Should comply
<100 cfu/g <50 cfu/g absence |
Complies
Complies Complies +55.2° Complies
0.5% 0.04% <5µg / g Complies
< 10 cfu/g < 15 cfu/g Not detected |
