D-(+)-Galactose, animal-origin free, vegetal-derived, cGMP

CAS Number: 59-23-4   |   Synonyms: GAL; aldehydo-D-galactose; (2R,3S,4S,5R)-2,3,4,5,6-pentahydroxyhexanal; aldehydo-D-galacto-hexose


Product InfoStructurePhysical PropertiesProduct DataTransportation DataSpecification Sheet

PRODUCT INFORMATION

Product Name:
D-(+)-Galactose, animal-origin free, vegetal-derived, cGMP

Product Description:
NF / EP

Quality Grade:
cGMP

Usage Unit:
KG

Source:
Peach Gum Tree resin

Synonyms:
GAL; aldehydo-D-galactose; (2R,3S,4S,5R)-2,3,4,5,6-pentahydroxyhexanal; aldehydo-D-galacto-hexose

STRUCTURE

NF / EP

SKU: 59234cGMP Category:
PHYSICAL PROPERTIES
S.NOPropertyValueReference
PRODUCT DATA

Molecular Formula:
C6H12O6

Molecular Weight:
180.16

EC Number:
200-416-4

Category:
CARBOHYDRATES

Functional Categories:
-

Purity Value:
-

Storage Temperature:
-

INCI Name:
GALACTOSE

TRANSPORTATION DATA

UN Class:
-

UN Packing Group:
-

Harmonized Tariff Number:
2940.00.6000

UN Number:
-

SPECIFICATION SHEET

Rev No:
2

SPECIFICATION DATA

S.NOGroupingAnalytical TestSpecification
1USP/NF--
2-Appearance of SolutionConforms
3-Identification AConforms
4-Identification BConforms
5-Sp. Rot.+78.0 to 81.5°
6-AcidityConfirms
7-Water (K-F)NMT 1.0%
8-Ash (residue on ignition)NMT 0.1%
9--BaConforms
10--Pb≤0.5 ppm
11-Metals (ICP)Conforms
12Microbiological Specifications--
13-Total Aerobic (CFU/g)≤1000 CFU/g
14-Mold and Yeast (CFU/g)≤100 CFU/g
15-SalmonellaAbsence
16-E. ColiAbsence
17-Staphylococcus aureusAbsence
18-Pseudomonas aeruginosaAbsence
19EP--
20-AppearanceWhite to almost white, crystalline powder
21-Appearance of SolutionConforms
22-Identification AConforms
23-Identification BConforms
24-Identification CConforms
25-Acidity or AlkalinityConforms
26--BaConforms
27--Pb≤0.5 ppm
28-Water (K-F)≤1.0%
29-Sulfated Ash≤0.1%
30Microbiological Specifications--
31-TAMC≤100 CFU/g
32-Assay (HPLC)97.0-102.0%
33-Impurity A and B≤1.0%
34-Each unspecified impurity≤0.3%
35-Total Impurities≤2.0%
36-Protein≤0.1 mg/ml
37-Endotoxins (EU/g)≤10 EU/g
38Residual Solvents (GC)--
39-Ethanol≤500 ppm
40-Methanol≤100 ppm
41-Methyl Isobutyl Ketone≤500 ppm
42Manufacturing and Regulatory Data--
43-Date of Manufacture-
44-Retest Date2 years

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