Trans-4-methylcyclohexylamine HCL
BATCH NO:20050301
QUANTITY:25kg
MANUF DATE:2005/03/01
EXPIRY DATE:2008/03/01
| TEST |
STANDARD |
RESULT |
| Description |
White Crystals |
qualitied |
| Melting point |
260-264oC |
261-263oC |
| Assay of trans isomer |
≥99% |
99.6% |
| Cis-isomer |
≤0.5% |
0.15% |
| Total Inpurity |
≤1% |
qualified |
| Reside on ignition |
≤0.1% |
0.05% |
| Loss on drying |
≤0.5% |
0.2% |
CONCLUSION:conforms to In-house standard.
|
4-[2-(3-ethyl-4-methyl-2-oxy-3-pyrrolinyl-1-methylamide)-ethyl]benzenesulfonamide
Other Name:BENSU
Batch No.:20050305
Quantity:50kg
MANUF DATE:2005/03/05
EXPIRY DATE:2008/03/05
| TEST |
Specification |
Result |
| Appearance: |
white crystalline powder |
conforms |
| Identification: |
IR conform Reference Standard |
conforms |
| Melting point: |
179-181oC |
180-181oC |
| Loss on drying: |
≤0.2% |
0.10% |
| Residue on igmition: |
≤0.1% |
0.08% |
| Assay(HPLC on dried basis) |
≥98.0% |
99.0% |
Conclusion:conforms to In-house Standard.
|
3-ethyl-4-methyl-3-pyrroline-2-one
Batch No.:20050301
Quantity:200kg
MANUF DATE:2005/03/01
EXPIRY DATE:2005/08/01
| TEST |
STANDARD |
RESULT |
| Appearance |
Yellowish crystalline powder |
conforms |
| melting point |
101-103oC |
102-103oC |
| Assay(HPLC) |
≥98.5% |
99.5% |
| Loss on drying |
≤0.5% |
0.15% |
conolusion:conforms to In-house standard.
|
Trans-4-methyl cyclohexyl isocyanate
Batch No.:20050205
Quantity:100kg
MANUF DATE:2005/02/05
EXPIRY DATE:2008/02/05
| TEST |
STANDARD |
RESULT |
| Appearance |
Colourless transparent dazzling liquid |
Conforms |
| Assay |
≥98.5% |
99.15% |
| Cis-isomer |
≤0.5% |
0.11% |
| Total Inpurity |
≤1% |
qualified |
Condusion conforms to In-house standard.
|
L-Homoarginine
Batch No.:20050201
Quantity:25kg
MANUF DATE:2005/02/01
EXPIRY DATE:2008/02/01
| TEST |
STANDARD |
RESULT |
| Appearance |
white crystalline powder |
conforms |
| melting point |
210-215oC |
212-214oC |
| Assay |
98.5% |
99.5% |
| Luminous intensity |
+18- +20o |
+18.2- +19o |
| Los on drying |
≤0.5% |
0.18% |
condusion: conforms to In-house standard.
|
Batch No.:20050201
Quantity:25kg
MANUF DATE:2005/02/01
EXPIRY DATE:2008/02/01
Zonisamide
| TEST |
STANDARD |
RESULT |
| Appearance |
white crystalline powder |
conforms |
| Melting point |
161-163oC |
162-163oC |
| Assay |
≥98.5% |
99.5% |
| Indiridual impurity |
≥0.5 |
conforms |
| Total impurities |
≤1.0% |
conforms |
| Loss on drying |
≤0.5% |
0.20% |
| Residue on ignition |
≤0.1% |
conforms |
| Heavy metals |
≤10ppm |
conforms |
condusion:conforms to In-house standard
|
trans-4-methylcyclohexylamine
BATCH NO:20050301
QUANTITY:25kg
MANUF DATE:2005/03/01
EXPIRY DATE:2006/03/01
| TEST |
STANDARD |
RESULT |
| Appearance |
Colourless transparent liquid |
conforms |
| Assay |
≥98.5% |
99.35% |
| cis-isomer |
≤0.5% |
0.15% |
| Loss on drying |
≤0.5 |
0.20% |
CONCLUSION:conforms to In-house standard.
|
Glimepiride
BATCH NO:20050102
QUANTITY:30kg
MANUF DATE:2005/01/02
EXPIRY DATE:2006/01/02
| Tests |
Standards |
Results |
| Appearance |
White or almost white power. |
qualified |
| Solubility: |
Practically insoluble in water,soluble in dimethylformamide,slightly soluble in methylene chloride,Very slightly soluble in methanol.It dissolves in dilute alkali hydroxides and dilute acids.It shows polymorphism. |
qualified |
| Identification: |
IR |
qualified |
| Impurity A: |
≤0.8% |
0.13% |
| Related substances: |
Impurity B:≤0.4% |
0.36% |
| |
Impurity D:≤0.2% |
0.06% |
| |
Any other impurity:≤0.1% |
0.08% |
| |
Sumof impurities other than B:≤0.5% |
0.13% |
| |
Disregard limit:≤0.05% |
qualified |
| Heavy metals: |
≤10ppm |
qualified |
| Water: |
≤0.5% |
0.20% |
| Sulphated ash: |
≤0.1% |
0.06% |
| Assay(on dried basis): |
97.0%-102.0% |
99.45% |
|
