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Reducing substances. Carry out the test within 4 h of preparation of solution S. To 20.0 mL of solution S add 1 mL of dilute sulfuric acid R and 20.0 mL of 0.002 M potassium permanganate. Boil for 3 min. Cool. Add 6 mL of potassium iodide solution R and titrate immediately with 0.01 M sodium thiosulfate, using 0.25 mL of starch solution R as indicator. Carry out a titration using 20.0 mL of the blank solution (see solution S). The difference between the titration volumes V of 0.01 M sodium thiosulfate is not greater than 0.3 mL for type I closures or 7.0 mL for type II closures.

還原性物質(zhì)。在溶液 S 制備后 4 小時內(nèi)進行試驗。取 20.0 mL 溶液 S，加 1 mL 稀硫酸 R 和 20.0 mL 0.002 M 高錳酸鉀溶液，煮沸 3 分鐘。冷卻后，加 6 mL 碘化鉀溶液 R，立即用 0.01 M 硫代硫酸鈉滴定，用 0.25 mL 淀粉溶液 R 作指示劑。用 20.0 mL 空白溶液（見溶液 S）進行滴定。0.01 M 硫代硫酸鈉的滴定體積V的差值，對于 I 型瓶塞不大于 0.3 mL，對于 II 型瓶塞不大于 7.0 mL。

Extractable zinc: maximum 5 μg of extractable Zn per millilitre of solution S.

可提取鋅：每毫升溶液 S 中可提取鋅的最大值為 5 μg。

Atomic absorption spectrometry (2.2.23, Method I).

原子吸收光譜法（2.2.23，方法 I）。

Test solution. Use an appropriate volume of solution S and add 1 per cent V/V of a 103 g/L solution of hydrochloric acid R. The solution S if results are outside the calibration range, dilute 10.0 mL of solution S to an appropriate volume with 0.1 M hydrochloric acid.

試驗溶液。使用適量體積的溶液 S，加入 1% V/V的 103 g/L 鹽酸溶液 R。若溶液 S 的結(jié)果超出校準范圍，取 10.0 mL 溶液 S，用 0.1 M 鹽酸稀釋至適當(dāng)體積。

Reference solutions. Prepare the reference solutions using zinc standard solution (10 ppm Zn) R, diluting with a 103 g/L solution of hydrochloric acid R or 0.1 M hydrochloric acid.

對照溶液。用鋅標準溶液（10 ppm Zn）R，用 103 g/L 鹽酸溶液 R 或 0.1 M 鹽酸稀釋，制備對照溶液。

Source: zinc hollow-cathode lamp.

光源：鋅空心陰極燈。

Wavelength 213.9 nm.

波長 213.9 nm。

Atomisation device: air–acetylene flame.

原子化裝置：空氣 - 乙炔火焰。

Fragmentation. For closures intended to be pierced by a hypodermic needle, carry out the test as follows: fill 12 clean vials with a volume of water R corresponding to the nominal volume minus 4 mL, close the vials with the closures to be examined and secure with a cap. Using a needle fitted to a clean syringe, inject 1 mL of water R into a vial and remove 1 mL of air; carry out this operation 4 times for each closure, changing the piercing site each time. Use a new needle for each rubber and check that the needle is not blunted during the test. Filter the liquid in the vials through a membrane filter (nominal pore size 0.5 μm). Count the fragments of  rubber in the closure visible to the naked eye. Not more than 5 fragments are visible. This limit is based on the assumption that fragments with a diameter of not less than 50 μm are visible to the naked eye; in case of doubt or dispute, examine the fragments under a microscope to verify their nature and size.

 穿刺落屑：對于擬用皮下注射針頭穿刺的瓶塞，按以下方式測試：將 12 個潔凈小瓶裝入體積為 “標稱體積減 4 mL” 的水R，用待檢測瓶塞塞住小瓶并用瓶蓋固定；使用安裝在潔凈注射器上的針頭，向小瓶中注入 1 mL 水 R 并排出 1 mL 空氣，對每個瓶塞進行 4 次該操作（每次更換穿刺部位）；每個橡膠瓶塞使用新針頭，并檢查針頭在測試中未變鈍；將小瓶中的液體通過薄膜（標稱孔徑 0.5 μm）過濾，計數(shù)瓶塞中肉眼可見的橡膠碎屑，肉眼可見的碎屑不得超過 5 個。該標準基于 “直徑不小于 50 μm 的碎片肉眼可見” 的假設(shè)；如有疑問或爭議，在顯微鏡下檢查碎屑以確認其性質(zhì)和大小。