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Is. Alteplase 50 img for Injection
en. Atazanavir 300 mg Capsule
c^. Biphasic Insulin Aspart 100 lU/ml Injection ^n^ penfill
(^. Ticagrelor 90 mg Tablet
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Biphasic Insulin Aspart 100 ILJ/ml Injection "iri^^ penfill
Atazanavir 300 mg Capsule
Alteplase 50 mg for Injection
Albumin human 20% Injection
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- wrsawiu^naviss^^^lu finished product specification
- <^m^NTu ^i^tj^spin* *\ anvi wa
- Immunoelectrophoresis
- Ouchterlony test (Double immunodiffusion)
5. Heme content
4. Albumin
3. Total protein
2. pH
1. Identification
^^niaaijliYn*iviFiaflt)a* Finished product
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12. Heat stabilizers aivi wu
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11. Potassium content
10. Aluminium content
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7. Sterility test
6. Sodium content
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7.2
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- 60-100%
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- 6.8-7.8
- ^Ti^WTUonuvtazi/lu finished product specification
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12. Particulate matter
11. rt-PA monomer determination
10. Single-chain rt-PA determination
9. Reconstitution time
8. Water content
7. pH
6. Uniformity of dosage units
5. Sterility test
4. Bacterial endotoxins
3. Clot lysis
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1. Identification
Finished product
pmuui-a
50 ml 1Alteplase 50 mg ^i^n^t vi^
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Alteplase 50 mg for Injection ^<Hl^^A
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Specifications
Sulfuric acid
Residue on ignition
Water
ImpurityIndividual impurity
Total impurities
Assay
Identification
Test items
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4.2.1
4.2
viej.1 ^a a.l ^ja- tnvkecuanpn
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product
6. Total Impurities
5. Related proteins
4. Limit of high molecular weight
proteins
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(finished product specification) n<auvia^<5^vrin
finished
3.1
3.
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2.2
2.1 n^^^vianw^pi1iu'iJ'3t!tvi?ilv)a
2.
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1.1 luaiflVym^^vi^iiia'uw^fuan (via. 2, via.3, via.4 via a.2
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- 16.4-22.9 p/ml j
10. Bacterial endotoxins
9. Sterility test
8. Preservative
7. Zinc content
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1.
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- ^T^awTUdnuvi'j^ulu finished product specification
- Pinawnwiuv^^stjlu finished product specification
- 95.0-105.0% of the labeled amount of Ticagrelor
- wii^wiuw'iijvi'sstj'tu finished product specification
5. Degradation products
4. Dissolution Test
3. Uniformity of dosage units
2. vJiuini^nanaimu
1. Identification
Finished product
fmmi^-3 tu
uiwiw^a^j fmuu^ Tuviw^^ ^ufmanauvi
Ticagrelor 90 mg
1.
2. hi 1 iJJ
3.
4.
Ticagrelor 90 mg Tablet^faa
n.e. m
4.
(Raw materia
(Certification of analysis) tutnfuvid-nil'u
Certificate of pharmaceutical
3.2
3.1
3.
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Biphasic Insulin Aspart 100 lU/mlInjection ^^ penfill (s:.^)
Atazanavir 300 m Capsule (s^.lo)
Alteplase 50 mg for Injection (sl.h)
Albumin human 20% Injection (sCte)
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