This document is a certificate of analysis from Systacare Remedies for 1.0 ml clear glass ampoules. It details the specifications, results of tests conducted, and conclusions about the material. Key information includes: the material is 1.0 ml clear glass ampoules with a white snap-off ring and yellow neck ring; dimensions and weights were tested against specifications; hydrolytic resistance and arsenic level were also tested with complying results. The conclusion is that the material complies with all specifications.
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18PM0044- 1.0 ml Clear White Ring snap off & Yellow ring on neck glass Ampoule.docx
This document is a certificate of analysis from Systacare Remedies for 1.0 ml clear glass ampoules. It details the specifications, results of tests conducted, and conclusions about the material. Key information includes: the material is 1.0 ml clear glass ampoules with a white snap-off ring and yellow neck ring; dimensions and weights were tested against specifications; hydrolytic resistance and arsenic level were also tested with complying results. The conclusion is that the material complies with all specifications.
This document is a certificate of analysis from Systacare Remedies for 1.0 ml clear glass ampoules. It details the specifications, results of tests conducted, and conclusions about the material. Key information includes: the material is 1.0 ml clear glass ampoules with a white snap-off ring and yellow neck ring; dimensions and weights were tested against specifications; hydrolytic resistance and arsenic level were also tested with complying results. The conclusion is that the material complies with all specifications.
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.