Shandong Pharmaceutical Glass Co., Ltd.

[Rubber & Plastic Division]

Yaobo Rd.1#, Yiyuan County, Zibo City, Shandong, China.Zip Cod: 256100.Tel. 86-533-3243561

Certificate of Analysis
JL005 A/1 Date: 8/3/2023
Commodity Bromo-butyl Rubber Stopper for Injection, 20mm

Type of Rubber Bromo-butyl Packed in: Tyvek Bag Quantity: 3,000,000 pcs

Size of Spec.: 20-A Treatment: WFI Washed,Siliconized, RTS Batch No.: 20230718

Color Scheme: Grey Mfg Date: 7/18/2023 Expire: 7/18/2028

Executive STD CFDA Norm: YBB00052005 -2015, Reference to the current Version of EP <3.2.9> and USP <381>

Visual and Dimensional Test as per in-house Specification

Appearance Basic Dimensions

Defects Ac/n Number of Items Limit Result Single Judge

Class A 0/500 0 Flange Diameter 18.80+0.25/-0.20 18.71~18.81mm Complies
Class B 5/500 0 Total Height 8.80±0.30 8.62~8.79mm Complies
Class C 14/500 0 Dia. Of Plunger part 13.20±0.10 13.13~13.26mm Complies
Class D 21/500 2 Flange Thickness 3.30±0.25 3.2~3.38mm Complies
Result Complies Thickness of puncture area 1.80±0.25 1.75~1.89mm Complies
Test Items Limit as per In-house specification Result Single Judge
Identification(Infrared
Comply with the standard Spectrogram Complies with Complies
Spectrogram)
Ash Content(%) ≤50.0 47.8 Complies
Physical and Chemical Test Limit as per CFDA Norm, EP 3.2.9 and USP <381> Result Single Judge
Absorbance（220-360nm） ≤0.20 0.01 Complies
Solution S not greater than ref. suspension II(2.2.1)
Turbidity/Opalescence pass(1NTU) Complies
(Not more than 6.0NTU)
Colouring (Clarity) Not more than GY5 <Y-green No.5 Complies
Acidity or alkalinity (20ml of
Max. 0.3ml 0.01M NaOH, or Max. 0.8ml 0.01M HCl 0.02ml NaOH Complies
Solution S)

pH value change ≤1.0 (as per CFDA NormYBB00052005-2015) 0.28

Reducing substances
(oxidizables,calculated as ≤3.0ml 0.3 Complies
0.002mol/L KMnO4）
Ammonium (calculated as
≤2.0ppm ＜0.5 Complies
NH4+)mg/L
Extractable Zinc (calculated as
≤3.0, not more than 3ppm ＜0.5 Complies
Zn2+)μg /ml
Heavy metals( calculated as Pb2+)
≤1.0, not more than 1ppm ＜0.5 Complies
mg/L
Residue on evaporation
≤4.0 1.2 Complies
（mg/100ml）

Conductivity (µS/cm） ≤15 7.1 Complies

Volatile sulfides (mg/20cm2） ≤0.05 ＜0.05 Complies

Insoluable Particle 10.0μm≤60 25.0μm≤6 8.5 0.3 Complies

Function Test (Performance) Limit as per CFDA Norm, EP 3.2.9 and USP <381> Result Single Judge
Penetration force (N) Max.≤10N 2.8 Complies

Fragmentation (Coring) ≤5 fragments per 100penetration 0 Complies

Closure/Container integrity Matches well with container, no leakage Matched Complies

Self Sealing (after penetration) No trace of Methylene coloured solution found. Not found Complies
Tightness and puncture device N.A. This column is only for Infusion Rubber Stopper 28-
-- --
retention 32mm
Anti-freeze Resistance(after Lyo-
N.A. This column is only for Lyo-Closure -- --
process)
Slipping Test (average of max N.A. only for Plunger for cartridge and syringe -- --
force value for 10pcs) N.A. only for Plunger for cartridge and syringe -- --
N.A. This column is only for Plunger for glass cartridge
Leakage Test -- --
and syringe

Biological Test Limit as per CFDA Norm, EP 3.2.9 and USP <381> Result Single Judge

Bacteria Endotoxin Test <0.25EU/ml <0.25EU/ml Complies

Sterility Test [Only for Sterilized
N.A. This column is only for sterile product -- --
Closure]
If Sterilization has been completed, should provide the relative sterilization certificate of sterilization service provider, and list the
followings:

Sterilized by: N.A. Sterilization Batch No.: Date: --

Coating Quality (Only for Teflon Coated Closure) as per In-house Standard Result Single Judge

Resistance of Acid/Alkali Not Applicable, because the product is without coated -- --

Thermal Stability Test Not Applicable, because the product is without coated -- --
Infrared Spectrogram for coating
Not Applicable, because the product is without coated -- --
film

Final Conclusion: the batch product meets the requirements specified in CFDA Norm: YBB00052005 -2015.

Materials of
Bromo-butyl rubber elastomer, reinforcing filler, colorant, softening agent, vulcanization crosslinking agent.
Construction
The above batch rubber stopper meets the requirements for type I closures specified in general chapter 3.2.9 of the
Statement:
current version of EP and USP <381>, and ISO8362-2.

Inspected by: Wang Jingju Reviewed by: Li Dehong Approved by: Liu Jian

20MM BROMOBUTYL RUBBER STOPPER (20-A,

WASHED AND READY FOR STERILIZE IN TYVEK PACK)

POPULAR PHARMACEUTICALS LTD. E-BIN:000002017-0102.

E-TIN:686624268512,IRC NO.BA-144101/260326120035519.