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ULTRA LABORATORIES PVT.

LIMITED
H.O - 213 CHETAK CENTRE ANNEX, 12/2 RNT MARG, INDORE- 452001
R.O. 34 FERNS RESIDENCY, OFF HENNUR MAIN ROAD,
K. NARAYANAPURA ROAD, KOTHANPUR, BANGALORE -560077

CERTIFICATE OF ANALYSIS

Report No. : SCH/DINJ/14/79A
Product : CEFTAZIDIME FOR INJECTION USP (ULTRAZIDIME 1000 MG)
Date of Receipt of sample : 11.07.2014
Batch No. : 14-02
Mfg. Date : Jul. 2014
Exp. Date : Jun.- 2016
Quantity of Sample : 100 Vials

RESULT OF TEST OR ANALYSIS WITH PROTOCOLS OF TEST OR ANALYSIS APPPLIED:
Test Specification Observation
Description
White to cream colour crystalline
powder.
White crystalline powder.
Identification
By HPLC
By Chemically
Positive
Positive
Pyrogens Should be complies Complies
Average fill weight Calculated by taking 20 vials 1282.9 mg
Uniformity of fill weight + 5% of average fill weight Within limit:
Loss on drying NMT 13.5% 12.09%
pH 5.0 to 7.5 (10% solution) 6.40
Sterility Should be sterile Complies
Particulate Matter Must be free from visual particles Complies
Sodium carbonate To be comply 9.356%
Pyridine NMT 0.4% 0.093%
Assay
Each vials contains: Claim Found % of Claim Limit
Ceftazidime (A blend of
Ceftazidime Pentahydrate &
sterile sodium carbonate USP)
1000.0 mg 1016.17 mg 101.61% NLT 90% & NMT
120% of claim

In the opinion of the undersigned the sample referred to above is of Standard Quality / is not of
standard Quality as defined in the Act and the rules made there under for the reasons given below.
Date: 25/07/2014

Test Carried out By :


Signature of person- in charge of Testing



ULTRA LABORATORIES PVT. LIMITED
H.O - 213 CHETAK CENTRE ANNEX, 12/2 RNT MARG, INDORE- 452001
R.O. 34 FERNS RESIDENCY, OFF HENNUR MAIN ROAD,
K. NARAYANAPURA ROAD, KOTHANPUR, BANGALORE -560077
CERTIFICATE OF ANALYSIS

Report No. : AAL/78/13/CDI/078
Product : CEFEPIME FOR INJECTION USP (ULTRAPIM 1000 MG)
Date of Receipt of sample : 08.01.2014
Batch No. : DC-227
Mfg. Date : Nov. - 2013
Exp. Date : Apr.- 2015
Quantity of Sample : 75 X 1GM Vials
RESULT OF TEST OR ANALYSIS WITH PROTOCOLS OF TEST OR ANALYSIS APPPLIED:
Test Specification Observation
Description
White to light yellow powder. filled in 20 ml flint glass
vial with duly rubber capped and yellow coloured flip
off sealed.
White to light yellow powder filled
in 20 ml flint glass vial with duly
rubber capped and yellow coloured
flip off sealed.
Identification
A) By TLC


B) HPLC
A) The intensity and the R
f
value of the spot in the
chromatogram of the Test solution correspond to
those in the chromatogram of the standard solution
B) The retention time of major peak in the
chromatogram of the assay preparation corresponds
to that in the chromatogram of the standard
preparation, as obtained in the assay

Complies


Complies
Average weight per vial ----- 1.9169 gm
Uniformity of weight of vial
NMT two of the individual weights (masses) deviate from
the avg. weight (mass) by more than +10% and none
deviates by more than +20%
Complies
Constituted solution
The solid dissolves completely leaving no visible residue
as undissolved matter.
Complies
Particulate Matter
When a solution examined under suitable condition of
visibility are clear and practically free from particle that
can be observed as visual inspection be unaided eye.
Max. particle limit > 10 = NMT 6000/container
Max. particle limit > 25 NMT 600/container
Complies


333.3/Container
9.3/container
Bacterial endotoxins Not more than 0.06 USP EU/mg Less than 0.06 USP EU/mg
Uniformity of dosage units L1 < 15.0 0.472%
pH Between 4.0 and 6.0 4.06
Water N.M.T. 4.0% 2.84 %
Limit of N-Methylpyrrolidine Not more than 1.0% Not detected
Related compounds Any other Impurity NMT 0.5% 0.46%
Sterility
(By membrane filtration)
The sample submitted complies/does not complies with
the test for detection of sterility including the test for
detection of fungi.
Complies
Assay
Each vials contains: Claim Found % of Claim Limit
Cefepime hydrochloride
USP eq. to cefepime
1000 mg 1021.6 mg 102.16% NLT 90.0% to NMT 115.0%
In the opinion of the undersigned the sample referred to above is of Standard Quality / is not of standard Quality as defined
in the Act and the rules made there under for the reasons given below.
Date: 23/01/2014

Test Carried out By :


Signature of person- in charge of Testing

ULTRA LABORATORIES PVT. LIMITED
H.O - 213 CHETAK CENTRE ANNEX, 12/2 RNT MARG, INDORE- 452001
R.O. 34 FERNS RESIDENCY, OFF HENNUR MAIN ROAD,
K. NARAYANAPURA ROAD, KOTHANPUR, BANGALORE -560077

CERTIFICATE OF ANALYSIS

Report No. : SCH/TAB/14/109
Product : CEFPODOXIME PROXETIL TABLETS USP 100 MG [CEFPOD]
Date of Receipt of sample : 30.04.2014
Batch No. : 14-01
Mfg. Date : Apr. - 2014
Exp. Date : Mar. - 2017
Quantity of Sample : 100 TABLET

RESULT OF TEST OR ANALYSIS WITH PROTOCOLS OF TEST OR ANALYSIS APPPLIED:

Test Specification Observation
Description
Cream coloured circular biconvex
film coated tablets, plain on both
side.
Cream coloured circular
biconvex film coated tablets,
plain on both side.
Identification By HPLC Positive
Average Weight of Tablets
Calculated by taking weight of 20
tablets.
281.4 mg
Uniformity of Wt. of Tablets + 5% of AVG. weight Within Limit
Water NMT 5.0% 4.37%
Dissolution NLT 70% 80.18% to 83.23%
Disintegration time NMT 30 min. 7 min.
Physical Parameter:
Diameter 9.3 mm + 0.2 mm 9.10 mm
Thickness 4.2 mm + 0.2 mm 4.28 mm
Assay :Each Film coated
Tablet Contains:
Claim Found % of claim Limit
Cefpodoxime proxetil USP
eq. to Cefpodoxime
100 mg 99.72 mg 99.72% 90.0% to 110.0%

In the opinion of the undersigned the sample referred to above is of Standard Quality / is not of standard
Quality as defined in the Act and the rules made there under for the reasons given below.
Date: 01/05/2014

Test Carried out By :


Signature of person- in charge of Testing


ULTRA LABORATORIES PVT. LIMITED
H.O - 213 CHETAK CENTRE ANNEX, 12/2 RNT MARG, INDORE- 452001
R.O. 34 FERNS RESIDENCY, OFF HENNUR MAIN ROAD,
K. NARAYANAPURA ROAD, KOTHANPUR, BANGALORE -560077

CERTIFICATE OF ANALYSIS

Report No. : SCH/TAB/14/011
Product : CEFPODOXIME PROXETIL TABLETS USP 200 MG [CEFPOD]
Date of Receipt of sample : 16.01.2014
Batch No. : 14-01
Mfg. Date : Jan. - 2014
Exp. Date : Dec. - 2016
Quantity of Sample : 100 TABLET

RESULT OF TEST OR ANALYSIS WITH PROTOCOLS OF TEST OR ANALYSIS APPPLIED:

Test Specification Observation
Description
Yellow to dark yellow coloured,
circular, biconvex, film coated
tablet plain on both side.
Yellow coloured, circular, biconvex,
film coated tablet plain on both
side.
Identification By HPLC Positive
Average Weight of Tablets
Calculated by taking weight of
20 tablets.
536.6 mg
Uniformity of Wt. of Tablets + 5% of AVG. weight Within Limit
Water NMT 5.0% 4.14%
Dissolution NLT 70% 83.02% to 88.50%
Disintegration time NMT 30 min. 2 min.
Physical Parameter:
Diameter 14.0 mm + 0.2 mm 13.90 mm
Thickness 4.5 mm + 0.2 mm 4.40 mm
Assay :Each Film coated
Tablet Contains:
Claim Found % of claim Limit
Cefpodoxime proxetil USP
eq. to Cefpodoxime
200 mg 199.13 mg 99.56% 90.0% to 110.0%

In the opinion of the undersigned the sample referred to above is of Standard Quality / is not of standard
Quality as defined in the Act and the rules made there under for the reasons given below.
Date: 17/01/2014

Test Carried out By :


Signature of person- in charge of Testing



ULTRA LABORATORIES PVT. LIMITED
H.O - 213 CHETAK CENTRE ANNEX, 12/2 RNT MARG, INDORE- 452001
R.O. 34 FERNS RESIDENCY, OFF HENNUR MAIN ROAD,
K. NARAYANAPURA ROAD, KOTHANPUR, BANGALORE -560077

CERTIFICATE OF ANALYSIS

Report No. : SCH/DS/14/30
Product : CEFPODOXIME PROXETIL FOR ORAL SUSPENSION USP (CEFPOD)
Date of Receipt of sample : 22.05.2014
Batch No. : 14-06
Mfg. Date : May - 2014
Exp. Date : Apr. - 2016
Quantity of Sample : 12 BOTTLES

RESULT OF TEST OR ANALYSIS WITH PROTOCOLS OF TEST OR ANALYSIS APPPLIED:

Test Specification Observation
Description
Off white crystalline powder.
After reconstitution off white
flavoured suspension, filled in
plastic bottle.
Off white crystalline powder.
After reconstitution off white
flavoured suspension, filled in
plastic bottle.
Identification
By HPLC

Positive
Water NMT 1.5% 0.67%
pH 4.0 to 5.5 4.70
Average net content NLT 15.0 gm/30.0 ml 15.1784 gm
Uniformity of weight of net
content
To comply Within limit
Assay
Each 5 ml contains: Claim Found % of claim Limit
After Reconstitution
Cefpodoxime Proxetil USP
Eq. to anhydrous Cefpodoxime
50.0 mg 52.73 mg 105.46%
NLT 90.0% &
NMT 110.0% of
claim
Stability After 7 Days
Cefpodoxime Proxetil USP
Eq. to anhydrous Cefpodoxime
48.94 mg 97.88%
NLT 80.0% of
claim

In the opinion of the undersigned the sample referred to above is of Standard Quality / is not of
standard Quality as defined in the Act and the rules made there under for the reasons given below.
Date: 29/05/2014

Test Carried out By :


Signature of person- in charge of Testing


ULTRA LABORATORIES PVT. LIMITED
H.O - 213 CHETAK CENTRE ANNEX, 12/2 RNT MARG, INDORE- 452001
R.O. 34 FERNS RESIDENCY, OFF HENNUR MAIN ROAD,
K. NARAYANAPURA ROAD, KOTHANPUR, BANGALORE -560077

CERTIFICATE OF ANALYSIS

Report No. : SCH/SYR/14/101
Product : VITAZINK SYRUP
Date of Receipt of sample : 30.04.2014
Batch No. : 14-06
Mfg. Date : Apr. - 2014
Exp. Date : Sep. - 2015
Quantity of Sample : 12x200ml
RESULT OF TEST OR ANALYSIS WITH PROTOCOLS OF TEST OR ANALYSIS APPPLIED:

Test Specification Observation
Description
Brown colour solution filled in
amber colour pet bottle.
Brown colour solution filled in
amber colour pet bottle.
pH 4.0 to 5.5 5.02
Weight per ml. 1.15 to 1.25 gm/ml 1.20 gm/ml
Average volume NLT 200.0 ml 201.0 ml
Assay:
Each 15.0 ml contains Claim Found % of Claim Limit
Riboflavin sodium phosphate
eq. to Riboflavin BP
0.5 mg 0.5213 mg 104.26% NLT 90.0%
Vitamin B
6
BP 0.5 mg 0.8025 mg 160.50% NLT 90.0%
Niacinamide BP 10 mg 13.1077mg 131.077% NLT 90.0%
D-Panthanol USP 0.5 mg 0.548 mg 109.60% NLT 90.0%
Vitamin D
3
BP 200 IU 379.2 IU 189.6% NLT 90.0%
Zinc sulphate BP
[eq. to elemental zinc 3.75 mg]
3.75 mg 3.79 mg 101.06% 90 to 110%
Protein hydrolysate 20% 1.0 gm 0.9820 gm 98.20% 90 to 110%
Magnesium chloride BP 2.5 mg 2.51 mg 100.40% 90 to 110%
Manganese chloride BP 0.1 mg 0.0989 mg 98.90% 90 to 110%
Iron Choline citrate 20 mg 19.95 mg 99.75% 90 to 110%
Calcium Gluconate BP 20 mg 20.14 mg 100.70% 90 to 110%
L-Lysine Monohydrochloride USP 15 mg 15.18mg 101.20% 90 to 110%

In the opinion of the undersigned the sample referred to above is of Standard Quality / is not of standard
Quality as defined in the Act and the rules made there under for the reasons given below.
Date: 03/05/2014

Test Carried out By :


Signature of person- in charge of Testing



ULTRA LABORATORIES PVT. LIMITED
H.O - 213 CHETAK CENTRE ANNEX, 12/2 RNT MARG, INDORE- 452001
R.O. 34 FERNS RESIDENCY, OFF HENNUR MAIN ROAD,
K. NARAYANAPURA ROAD, KOTHANPUR, BANGALORE -560077

CERTIFICATE OF ANALYSIS

Report No. : SCH/TAB/14/001
Product : LEVOCETIRIZINE TABLETS IP 5 MG [LEVOTIN-5MG]
Date of Receipt of sample : 03.01.2014
Batch No. : 14-01
Mfg. Date : Jan. - 2014
Exp. Date : Dec. - 2015
Quantity of Sample : 100 TABLET

RESULT OF TEST OR ANALYSIS WITH PROTOCOLS OF TEST OR ANALYSIS APPPLIED:

Test Specification Observation
Description
Light yellow coloured, round
shaped, biconvex, film coated
tablets having plain on both
sides.
Light yellow coloured, round
shaped, biconvex, film coated
tablets having plain on both
sides.
Identification By HPLC Positive
Average weight of Tabs
Calculate by taking weight of 20
tablets. 170.00 mg + 3%
167.8 mg
Uniformity of Weight of Tabs +7.5% of Avg. Weight Within Limit
Uniformity of content 85.0% to 115.0% 93.90% to 105.54%
Disintegration time NMT 30 Min. 35 sec.
Physical Parameter:
Diameter 7.96 mm + 0.2 mm 8.09 mm
Thickness 3.1 mm + 0.2 mm 3.3 mm
Assay Claim Found % of claim Limit
Each film coated Tablet Contains:
Levocetirizine Dihydrochloride
USP
5.0 mg 4.99 mg 99.80%
NLT 90.0% &
NMT 110.0% of
claim
In the opinion of the undersigned the sample referred to above is of Standard Quality / is not of
standard Quality as defined in the Act and the rules made there under for the reasons given below.
Date: 04/01/2014

Test Carried out By :


Signature of person- in charge of Testing


ULTRA LABORATORIES PVT. LIMITED
H.O - 213 CHETAK CENTRE ANNEX, 12/2 RNT MARG, INDORE- 452001
R.O. 34 FERNS RESIDENCY, OFF HENNUR MAIN ROAD,
K. NARAYANAPURA ROAD, KOTHANPUR, BANGALORE -560077

CERTIFICATE OF ANALYSIS

Report No. : SCH/SYR/14/32
Product : LEVOCETIRIZINE DIHYDROCHLORIDE SYRUP (LEVOTIN SYRUP)
Date of Receipt of sample : 10.02.2014
Batch No. : 14-01
Mfg. Date : FEB. - 2014
Exp. Date : JAN.- 2016
Quantity of Sample : 12 BOTTLE

RESULT OF TEST OR ANALYSIS WITH PROTOCOLS OF TEST OR ANALYSIS APPPLIED:

Test Specification Observation
Description
Light yellow colour flavoured
syrup filled in amber colour pet
bottle
Light yellow colour flavoured
syrup filled in amber colour pet
bottle
Identification
Levocetirizine dihydrochloride IP

Positive
pH 4.5 to 6.0 4.70
Weight per ml. 1.15 to 1.25 gm/ml 1.17 gm/ml
Average volume NLT 30 ml 32.0 ml
Assay
Each 5 ml contains: Claim Found % of claim Limit
Levocetirizine dihydrochloride
IP
2.5 mg 2.48 mg 99.20%
NLT 90.0% & NMT
110.0% of claim

In the opinion of the undersigned the sample referred to above is of Standard Quality / is not of
standard Quality as defined in the Act and the rules made there under for the reasons given below.
Date: 11/02/2014

Test Carried out By :


Signature of person- in charge of Testing



ULTRA LABORATORIES PVT. LIMITED
H.O - 213 CHETAK CENTRE ANNEX, 12/2 RNT MARG, INDORE- 452001
R.O. 34 FERNS RESIDENCY, OFF HENNUR MAIN ROAD,
K. NARAYANAPURA ROAD, KOTHANPUR, BANGALORE -560077

CERTIFICATE OF ANALYSIS

Report No. : SCH/TAB/14/66
Product : NIMESULIDE & PARACETAMOL TABLETS [NIMILID]
Date of Receipt of sample : 23.03.2014
Batch No. : 14-04
Mfg. Date : Mar. - 2014
Exp. Date : Feb. - 2017
Quantity of Sample : 100 TABLET

RESULT OF TEST OR ANALYSIS WITH PROTOCOLS OF TEST OR ANALYSIS APPPLIED:

Test Specification Observation
Description
Light orange coloured
elongated biconvex uncoated
tablets, having break line on
one side & plain on other side.
Light orange coloured elongated
biconvex uncoated tablets, having
break line on one side & plain on
other side.
Identification
Nimesulide
Paracetamol
Positive
Positive
Average Weight of Tablets
Calculated by taking weight of
20 tablets.
765.4 mg
Uniformity of Wt. of Tablets + 5% of AVG. weight Within Limit
Disintegration time NMT 15 min. 6 min .
Physical Parameter:
Length 19.0 mm + 0.2 mm 19.20 mm
Thickness 6.0 mm + 0.2 mm 5.85 mm
Assay :Each Uncoated Tablet
Contains:
Claim Found % of claim Limit
Nimesulide BP 100 mg 101.34 mg 101.34%
90.0% to 110.0% of
claim
Paracetamol BP 500 mg 501.18 mg 100.23%
90.0% to 110.0% of
claim

In the opinion of the undersigned the sample referred to above is of Standard Quality / is not of standard
Quality as defined in the Act and the rules made there under for the reasons given below.
Date: 24/03/2014

Test Carried out By :


Signature of person- in charge of Testing



ULTRA LABORATORIES PVT. LIMITED
H.O - 213 CHETAK CENTRE ANNEX, 12/2 RNT MARG, INDORE- 452001
R.O. 34 FERNS RESIDENCY, OFF HENNUR MAIN ROAD,
K. NARAYANAPURA ROAD, KOTHANPUR, BANGALORE -560077
CERTIFICATE OF ANALYSIS
Report No. : FP/LVP-2/14/U254035
Product : FLUCONAZOLE INJECTION USP (0.2% W/V) 100 ML
[FLUCOX]
Date of Receipt of sample : 20.02.2014
Batch No. : U254035
Mfg. Date : Feb. 2014
Exp. Date : Jan. 2017
Quantity of Sample : 50 BOTTLE
RESULT OF TEST OR ANALYSIS WITH PROTOCOLS OF TEST OR ANALYSIS APPPLIED:
TEST SPECIFICATION OBSERVATION
Description
A clear and almost colorless solution
essentially free from visible particles.
A clear and almost colorless solution
essentially free from visible particles.
Confirm
Identification
By HPLC
The retention time of the major peak in the
chromatogram of the assay preparation
corresponds to that in the chromatogram of
the standard preparation obtained as
directed in the assay.

The retention time of the major peak
in the chromatogram of the assay
preparation corresponds to that in the
chromatogram of the standard
preparation obtained as directed in
the assay.
Confirm
pH Between 4.50 and 7.00
5.99
Confirm
Related Compounds
NMT 0.1% of the single largest polar unknown
impurity is found and NMT 0.5% of the total
polar unknown impurities is found.
Confirms
Extractable Volume
The volume is not less than the nominal
volume.
102.0 ml
(Confirms)
Particulate matter for 100 ml nominal volume
For >10
60.00 particles per container
Confirm
NMT 6000 particles per cont.
For > 25
0.00 particles per container
Confirm
NMT 600 particles per cont.
Assay of Sodium Chloride
0.9056% w/v
100.62%
Between 95.00% and 105.00% of the
label claim (Label claim: 0.9% w/v)
Assay of Fluconazole (By
HPLC)
0.1978% w/v
98.90%
Between 90.00% and 110.00% of the
label claim (Label claim: 0.2% w/v)
Bacterial Endotoxin
< 0.416 EU/mg
Confirms
Not more than 0.416 EU/mg
Sterility Confirms It should be sterile

In the opinion of the undersigned the sample referred to above is of Standard Quality / is not of standard Quality as
defined in the Act and the rules made there under for the reasons given below.
Date: 07/03/2014

Test Carried out By :


Signature of person- in charge of Testing


ULTRA LABORATORIES PVT. LIMITED
H.O - 213 CHETAK CENTRE ANNEX, 12/2 RNT MARG, INDORE- 452001
R.O. 34 FERNS RESIDENCY, OFF HENNUR MAIN ROAD,
K. NARAYANAPURA ROAD, KOTHANPUR, BANGALORE -560077
CERTIFICATE OF ANALYSIS
Report No. : FP/LVP-2/14/U284029
Product : LEVOFLOXACIN INTRAVENOUS INFUSION (0.5% W/V) 100 ML [LEVODEX]
Date of Receipt of sample : 31.01.2014
Batch No. : U284029
Mfg. Date : Jan. 2014
Exp. Date : Dec. 2015
Quantity of Sample : 50 BOTTLE
RESULT OF TEST OR ANALYSIS WITH PROTOCOLS OF TEST OR ANALYSIS APPPLIED:
Test Specification Observation
Description
A Clear and yellow solution essentially free
from visible particles
A clear and yellow solution essentially free
from visible particles (Confirms)
Identification
For Levofloxacin
(BY HPLC)



For Glucose

The chromatogram obtained with the test
solution corresponds to the chromatogram
obtained with standard solution.

A copious red precipitate is formed.

The chromatogram obtained with the test
solution corresponds to the chromatogram
obtained with standard solution.
(Confirms)
A copious red precipitate is formed
(Confirms)
pH Between 3.80 and 5.80
5.05
(Confirms)
Extractable Volume
The volume is not less than the nominal
volume
106.0 ml
(Confirms)
Particulate matter for 100 ml nominal volume
For >10 NMT 6000 particles per cont.
120.00 particles per container
(Confirms)
For > 25 NMT 600 particles per cont.
6.67 particles per container
(Confirms)
Assay of Glucose
Between 95.00% and 105.00% of the label
claim (Label claim: 5.0% w/v)
4.9569% w/v
99.14%
(Confirms)
Assay of Levofloxacin (By
HPLC)
Between 90.00% and 120.00% of the label
claim (Label claim: 0.5% w/v)
0.5002% w/v
100.04%
(Confirms)
Related Substances
D-Ofloxacin
The relative retention times are about 1.0
for levofloxacin and 1.2 for D-ofloxacin.
The area of peak corresponds to D-
ofloxacin in the chromatogram obtained
with the test solution is NMT 2.0% of the
area of the principal peak.

The relative retention times are about 1.0
for levofloxacin and 1.2 for D-ofloxacin.
The area of peak corresponds to D-
ofloxacin in the chromatogram obtained
with the test solution is NMT 2.0% of the
area of the principal peak.
(Confirms)
Bacterial Endotoxin Not more than 0.5 EU/ml
< 0.5 EU/ml
(Confirms)
Sterility It should be sterile
Sterile
(Confirms)
In the opinion of the undersigned the sample referred to above is of Standard Quality / is not of standard Quality as
defined in the Act and the rules made there under for the reasons given below.
Date: 14/02/2014

Test Carried out By :


Signature of person- in charge of Testing

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