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SYSTACARE REMEDIES, AMRITSAR

QUALITY CONTROL DEPARTMENT


CERTIFICATE OF ANALYSIS
(PACKAGING MATERIAL)
SOP No.: SYS/SOP/QC/052/01 Format No: SYS/SOP/QC/052/01-F03
Name of the Material : 1.0 ml Clear White Ring snap off & Yellow ring on Neck Glass
Ampoule
GRN No.: 18PM0044 AR No : PM/18/07/11/07
Lot No.: NA Sampled Qty: 120 Ampoule.
Mfg. Date: NA Date of Sampling: 09/07/2018
Exp. Date: NA Name of Shree Naina
Supplier: Packwel
Name of Shree Naina Packwel Date of Analysis: 09/07/2018
Manufacturer:
Pack Size: 34 x 700, Ampoule. Date of Release: 11/07/2018
Ref. STS No. : SYS/STS/PM/137/02
Page 1 of 1

S. No. TEST SPECIFICATION RESULTS


1. Description 1.0 ml clear white ring snap 1.0 ml clear white
off & yellow ring on neck ring snap off &
glass ampoule, USP Type I yellow ring on neck
Ampoule. glass ampoule, USP
Type I Ampoule.
2. Dimension:
(a). Wall Thickness 0.45 ± 0.0 3 mm. 0.45 mm.
(b). Body diameter 10.25 ± 0.50 mm. 10.16 mm.
(c). Base to Constriction Height 28.00 ± 1.00 mm. 27.22 mm.
(d). Total Height: 63.00 ± 1.00 mm. 63.16 mm.
(e). Neck Diameter: 6.75 ± 0.50 mm. 6.58 mm.
(f). Thickness From Ceiling NLT : 0.34 mm. 0.40 mm.
Height
(g). Total Weight of 10 NLT :15.00 g. 16.1731 g.
Ampoules:
(h). Flat Bottom Should be complies. Complies.

Analyzed By Checked By Approved By


Officer/Executive QC Head QA
(Sign & Date) (Sign & Date) (Sign & Date)
SYSTACARE REMEDIES, AMRITSAR
QUALITY CONTROL DEPARTMENT
CERTIFICATE OF ANALYSIS
(PACKAGING MATERIAL)
SOP No.: SYS/SOP/QC/052/01 Format No: SYS/SOP/QC/052/01-F03
Name of the Material : 1.0 ml Clear White Ring snap off & Yellow ring on Neck Glass
Ampoule
GRN No.: 18PM0044 AR No : PM/18/07/11/07
Lot No.: NA Sampled Qty: 120 Ampoule.
Mfg. Date: NA Date of Sampling: 09/07/2018
Exp. Date: NA Name of Shree Naina
Supplier: Packwel
Name of Shree Naina Packwel Date of Analysis: 09/07/2018
Manufacturer:
Pack Size: 34 x 700, Ampoule. Date of Release: 11/07/2018
Ref. STS No. : SYS/STS/PM/137/02
Page 1 of 1

(i). Mouth Diameter NMT 7.20 mm. 7.06 mm.


3. Hydrolytic Resistance NMT 1 ml of 0.02 N 0.68 ml.
Hydrochloric Acid should be
consumed.
4. Arsenic NMT: 0.1 ppm Complies.

CONCLUSION: The Material complies / does not comply as per Specification.

Analyzed By Checked By Approved By


Officer/Executive QC Head QA
(Sign & Date) (Sign & Date) (Sign & Date)

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