Specification of Grey butyl Rubber Stopper (20 mm)
This article describes the Specification of Grey butyl Rubber Stopper (20 mm), which is used to pack the glass bottles.
Specification of Grey butyl Rubber Stopper (20 mm)
I: Product Information of Grey butyl Rubber Stopper :
| Art Work Number : | NA |
| Supplier / Manufacturer : | As per approved vendor list |
| Sampling Procedure: | Sampling to be performed as per current version of SOP |
| Sample Quantity : | 20 No’s |
| Item Code : | As per SOP |
| Testing procedure: | Testing to be performed as per respective STP |
| Storage Condition: | Controlled Room Temperature |
| Sampling and Handling Precautions
(If Any): |
Use personal protective equipment while handling the material. |
II: Specification of Grey butyl Rubber Stopper:
| Sr. No. | Test | Specification | Reference |
| 1. | Description * | 20 mm grey colour Butyl Rubber Stopper | IH |
| 2. | Identification | It contracts to less than 1.2 times its original length within 30s | IH |
|
3. |
Physical Dimensions | ||
| A. Collar Diameter | 19.1 mm ± 0.2 mm |
IH
|
|
| B. Neck Diameter | 13.2 mm ± 0.2 mm | ||
| C. Thickness of Collar | 3.4 mm ± 0.2 mm | ||
| D. Total Height | 8.85 mm ± 0.3 mm | ||
| 4. | Physicochemical tests | ||
| A. Appearance of solution | Not more opalescent than Reference Suspension C for closures. Solution S is considered clear if its clarity is the same as that of water when examined as described above, or if its opalescence is not more pronounced than that of Reference Suspension A | USP | |
| B. Acidity or alkalinity | Not more than 0.3 ml of 0.01 N sodium hydroxide produces a blue color, or not more than 0.8 ml of 0.01 N hydrochloric acid produces a yellow color, or no titration is required. | ||
| C. Absorption | The A absorbance’s do not exceed 4.0 | ||
| D. Reducing Substance | The difference between the titration volume is not more than 7.0 mL | ||
| E. Heavy Metals | The colour of the solution in Test solution is not darker than that of the solution from the standard solution, and the intensity of the color solution of the Monitor Preparation is equal to or greater than that of the standard preparation. | ||
| F. Ammonium | After 5 minutes, any yellow color in the Test Solution is no darker than the Ammonium Standard Solution (no more than 2 ppm of NH4 in Solution S) | USP | |
| G. Volatile Sulfides | Any black stain on the paper produced by the test solution is not more intense than that produced by the control substance. | ||
| 5. | Functionality tests * | ||
| A. Penetrability
|
The force for piercing is no greater than 10 N (1 kgf) for each closure, determined with an accuracy of ±0.25 N (25 gf). | USP | |
| B. Fragmentation | There are no more than five fragments visible. This limit is based on the assumption that fragments with a diameter >50 μm are visible to the naked eye. In case of doubt or dispute, the particles are examined microscopically to verify their nature and size. | ||
| C. Self-Sealing Capacity | None of the vials contain any trace of blue solution | ||
Remark: * Test to be carried out for Retesting of Packing Material.
III: Revision History for specification of Grey butyl Rubber Stopper :
| Version No. |
Reason for Revision |
Change Control No. |
Effective Date |
