Gemcitabine 1000 mg Lyophilized Powder for Injection

Annex III
PT-01025-05
Batch: 01730 Expiry: 12/2020
Test date: 07-JAN-2019 Nº of test: K-2071
Properties Specifications Resu
White to off-white crystalline powder. No foreign particles in
Appearance
suspension should be observed.
Comp
<197U> UV Absorption: The sample spectrum should be
consistent with that of a standard
Comp
Identification
<621> H.P.L.C The retention time of the peak corresponding to
USP 41
the Gemcitabine sample should be consistent with the time and Comp
form of that of the standard.
Solution clarity The visually observed turbidity of the reconstituted sample
Comp
USP 41 <851> solution should not exceed that of the blank.
Test 1.B: The average number of particles present in the
Particulate matter analyzed units does not exceed 6000 particles equal to or greater
USP 41 <788> than 10 µm per container and does not exceed 600 particles
Comp
equal to or greater than 25 µm per container
N=10 N=30 10
Uniformity of dosage unit
AV ≤ L1 2.9
USP 41 <905> The individual content of any dosage unit is less
AV ≤ L1
than [1-(0.01).(L2)].M or greater than [1+(0.01). N/A
(L2)].M
pH
USP 41 <791>
2.7 – 3.3. 2.9
Water
USP 41 <921>
2.0 % max. 1.0
Cytosine: < 0.1%. 0.001
Purity Alpha Anomer: < 0.1%. N/D
USP 41 <621> Other impurities: < 0.2%. 0.04
Total impurities: < 0.3%. 0.06
Assay
USP 41 <621>
95 % - 105 % of the labeled amount. 98.1
Sterility
USP 41 <71>
No microbial growth should be observed. Comp
Bacterial Endotoxins < 0.
< 0.05 UE / mg de Gemcitabine HCl.
USP 41 <85> UE/m
Observations: N/A = Not applicable; N/D = Not detectable

Analyst: LG /Micro: SE-FG Resolution date: 25-JAN-2019

Book: 03 /Micro: 8-3 APPROVED
Page: 95 a 106 /Micro: 92-154
 Supervisor or person in charge: Franco Sanchez Head of Quality Control: Pablo Negro

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