ITEM |
SPECIFICATION |
TEST METHOD |
Properties (physical): |
|
|
Appearance |
White Crystalline, Free Flowing Powder |
USP29 -- <695> |
Odour |
Odourless |
Complies |
Bulk Density |
NLT0.70g/ml |
USP29 -- <616> |
As Tapped Density |
Meets the requirements of USP29 |
USP29 -- <616> |
Particle Size |
100% through 30 Mesh |
USP29 -- <811> |
Analytical Properties: |
|
|
Assay (HPLC) |
98.0—102.0% (on the dried basis) |
USP29 -- P2100(A)-- <621> |
Identification |
|
|
A: Infrared Absorption |
Meets the requirement |
A: USP29 -- P2100-- <197K> |
B: Tests for Chloride |
Meets the requirement |
B: USP29 -- <191> |
C: Retention time in the Assay |
Corresponds to the reference standard |
C: USP29 -- P2100-- <621> |
Transm |
>90.0% (10.0%Water Solut.-450nm) |
USP29 -- <197> |
Absorb |
<0.25a.u. (10.0% Water Solut.-280nm) |
USP29 -- <197> |
Specific Rotation〔α〕D20 |
+70.00°-- +73.00° |
USP29 -- <781S> |
PH (20mg/ml.aq.sol.) |
3.0—5.0 |
USP29 -- <791> |
Loss on Drying |
NMT0.5% |
USP29 -- <731> |
Residue on Ignition |
NMT0.1% |
USP29 -- <281> |
Chloride (Cl) |
16.2% --16.7% |
USP29 -- <221> |
Sulfate |
NMT 0.24% |
USP29 -- <221> |
Heavy Metals |
NMT 10 ppm |
USP29 -- <231>Ⅱ |
Iron (fe) |
NMT 10 ppm |
USP29 -- <241> |
Lead |
NMT 0.5 ppm |
AFS |
Arsenic (As) |
NMT 3.0 ppm |
USP29 -- <211>Ⅱ |
Mercury |
NMT 0.5 ppm |
AFS |
Organic volatile impurities |
Meets the Requirements |
USP29 -- <467>Ⅰ |
Impurities and Related Substances: |
|
|
N-Acetyl Glucosamine |
NMT 2.0% |
HPLC |
5-Hydroxymethyl-2-Furaldehyde |
NMT 0.50% |
HPLC |
Pyrazine |
NMT 0.10% |
HPLC |
2-Furaldehyde |
NMT 0.10% |
HPLC |
Individual Unknown Impurities |
NMT 0.10% |
HPLC |
Total Related Impurities |
NMT 2.5% |
HPLC |
Chloramphenicol |
Negative |
LC/MS |
Nitrofuran & Metabolites |
Negative |
HPLC |
Phenylalanine |
Negative |
GC |
Microbial: |
|
|
Total Aerobic |
NMT 1,000 cfu/g |
USP29 -- <61> |
Yeast & Mold |
NMT 100 cfu/g |
USP29 -- <61> |
E. Coli |
Negative in 1g |
USP29 -- <61> |
Salmonella |
Negative in 1g |
USP29 -- <61> |
Staphylococcus Aureus |
Negative in 10g |
USP29 -- <61> |
Enterobacteria & other gram neg |
NMT 100 cfu/g |
USP29 -- <61> |
Conclusion: |
Meets USP 29 standards |
Packaging and Storage: |
Store in tight, light-resistant containers under 25 ℃ |
Reason for Change: |
Updating Specification Format to USP 29 |
Effective Date: |
Code & Version: DGHCL30/1 |
Part No.: |
DG HCL 01 |
Prepared by: |
|
Approved by QC Dept.Manager: |
|
