Ticagrelor

5415400876 79

Ticagrelor 90 mg Tablets
Ticagrelor 90 mg Tablets

90
T

- film-coated tablet
1
- 1 Ticagrelor 90 mg
- Aluminium foil Blister pack

-
, ,
, ,

- 6

Finish product specification

1. Identification
2. Assay
3. Uniformity of dosage
units

Acceptance criteria
Positive identification
confirm
90.0 115.0% of the L.A.
of label claim
Positive identification
confirm

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4.Dissolution

Not Less Than 70%(Q) at

45 mins

NMT = Not more than

1.
(declare)

1.1 (.2 .3 .4
)
1.1.1 (
.2)
1.1.2 (
.3)
1.1.3 (
.4)
1.2 .1

(finished product specification)

finished product
specification
2.
2.1

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GMP-PIC/S


2.2

GMP-PIC/S US cGMP


3.
3.1
(Certification of analysis)

3.2
(Drug substance)


3.3 2
Long term stability

3.4 2

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4. 3



5.


()
6.
(
)
6.1

12

6.2

6.3








30

/
6.4

7.

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7.1

7.2

7.3

8.

1

:
1 = U.S.FDA approved drug products
information/The United States Pharmacopoeia