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洞家庄瑞雪制药有限公司 Dongjiazhuang Ruixue Pharmaceutical Co., Ltd

SJZ RUIXUE PHARMACEUTICAL CO ， 1 TD．

题目 Title	山梨糖醇液质量标准 Sorbitol solution quality standard		编号 Number	STP－ZL－01－Y001－A 3	共12页 12 pages
起草人 Straw man		审核人 Auditors		批准人 Approver
起草日期 Date of drafting		审核日期 Date of review		批准日期 Date of approval
颁发单位 Issued by		颁发日期 Date of issue	2024年01月31日 2024-01-31	生效日期 Effective Date	2024年01月31日 2024-01-31
分发单位 Distributing units	化验室生产部质量部供应储运部 Laboratory, Production Department, Quality Department, Supply, Storage and Transportation Department				分发号 Distribution number

一、目的：建立山梨糖醇液的质量标准，以保证产品的质量。
1. Purpose: To establish the quality standard of sorbitol solution to ensure the quality of the product.
二、范围：适用于山梨糖醇液的检验和判定。 2. Scope: It is suitable for the inspection and judgment of sorbitol solution.
三、依据：国家标准 GB1886．187－2016
3. Basis: National standard GB1886.187-2016
四、职责：质量部 QC 主管负责质量标准的起草及修订，质量部经理审核，质量负责人批准。QC按照此质量标准进行检验。
4. Responsibilities: The QC supervisor of the quality department is responsible for the drafting and revision of quality standards, the review of the manager of the quality department, and the approval of the person in charge of quality. QC is inspected in accordance with this quality standard.

正文  body
1．品名：山梨糖醇液   1. Product name: sorbitol liquid
拼音名：shanlitangchunye   Pinyin name: shanlitangchunye
2．物料代号：Y01   2. Material code: Y01
3．产品包装形式：不锈钢槽罐   3. Product packaging form: stainless steel tank
4．取样方法   4. Sampling method
按《取样标准操作规程》（文件编号：SOP－ZL－02－Y001－A\O）
According to the "Standard Operating Procedures for Sampling" (File No.: SOP-ZL-02-Y001-A\O)

5．质量标准 5. Quality standards

质量标准
Quality standards

序号 serial number	检测项目 Test items	国家标准 GB1886．187－2016 National standard GB1886.187-2016	内控标准 Internal control standards	检验频次 Inspection frequency
01	性状 Characters	无色透明的粘稠液体 Colorless, transparent, viscous liquid	无色透明的粘稠液体 Colorless, transparent, viscous liquid	铅、镍：3 Lead, nickel: 3
02	鉴别 Differential	试样溶液色谱图中的主峰保留时间应与标准溶液色谱图中的主峰保留时间一致。 The retention time of the main peak in the chromatogram of the sample solution should be consistent with the retention time of the main peak in the chromatogram of the standard solution.	试样溶液色谱图中的主峰保留时间应与标准溶液色谱图中的主峰保留时间一致。 The retention time of the main peak in the chromatogram of the sample solution should be consistent with the retention time of the main peak in the chromatogram of the standard solution.
03	山梨糖醇含量，w／\％ Sorbitol content, w/\%	$⩾ 50.0$	$⩾ 97.0$ （以干基计） $⩾ 97.0$ (on a dry basis)
04	水分， $w / %$ moisture, $w / %$	$⩽ 31.0$	$⩽ 31.0$
05	还原糖（以葡萄糖计），w／\％ Reducing Sugar (as Glucose), w/\%	$⩽ 0.21$	$⩽ 0.10$
06	总糖（以葡萄糖计）， $w / %$ Total sugars (in terms of glucose), $w / %$	$⩽ 8.0$	$⩽ 1.0$
07	炽灼残渣，w／\％ Residue on ignition, w/\%	$⩽ 0.1$	$⩽ 0.1$
08	硫酸盐（以 ${SO}_{4}$ 计）／（mg／kg） Sulfate ( ${SO}_{4}$ count)/(mg/kg)	$⩽ 50$	$⩽ 50$
09	氯化物（以 Cl 计）／（mg／kg） Chloride (Cl)/(mg/kg)	$⩽ 10$	$⩽ 10$
10	镍（ Ni ）／（ $mg / kg$ ） Nickel ( Ni )/( $mg / kg$ )	$⩽ 2.0$	$⩽ 2.0$
11	铅（ Pb ）／（ $mg / kg$ ） Lead ( Pb )/( $mg / kg$ )	$⩽ 1.0$	$⩽ 1.0$
12	PH 值（样品：水＝1：1） PH value (sample: water = 1:1)	－	5．5～7．5

5．1．上述各项均符合规定时，则判定该批次检验合格；有一项不合格时，则判定该批次不合格。
5.1. When the above items are in accordance with the regulations, the batch will be judged to be qualified; If one item is unqualified, the batch is judged to be unqualified.

5．2．铅、镍为抽检项目，对每个供应商的产品每季度抽检三批，不合格批次全部退货，同时再连续抽检三批，若仍不合格，则暂停该供应商供货，整改合格后方可供货。
5.2. Lead and nickel are sampling items, and each supplier's products are sampled three batches per quarter, and all unqualified batches are returned, and then three batches are continuously sampled.

5．3．贮存条件及注意事项  5.3. Storage conditions and precautions
5．3．1．贮存条件：应贮存在专用储罐内。   5.3.1. Storage conditions: should be stored in a special storage tank.
5．3．2．注意事项：运输时不得与有害物质或其他污染物混装、混运或在一起堆放。
5.3.2. Precautions: It shall not be mixed, transported or stacked together with hazardous substances or other pollutants during transportation.
5．4．有效期／复验期   5.4. Expiration date/re-inspection period
自生产之日起有效期／复验期为 12 个月／ 6 个月。
The validity/re-inspection period is 12 months/6 months from the date of manufacture.

6．内容 6. Content

6．1．性状 6.1. Traits

取适量试样，在自然光线下，观察色泽和状态。 Take an appropriate amount of sample, and observe the color and state under natural light.
标准规定：本品为无色透明的粘稠液体。 The standard stipulates: This product is a colorless and transparent viscous liquid.

6．2．鉴别 6.2. Identification

在测定山梨糖醇含量试验中，供试品溶液色谱图中的主峰保留时间应与对照品溶液色谱图中的主峰保留时间一致。
In the test of sorbitol content, the retention time of the main peak in the chromatogram of the test solution should be consistent with the retention time of the main peak in the chromatogram of the reference solution.

标准规定：供试品溶液色谱图中的主峰保留时间应与对照品溶液色谱图中的主峰保留时间一致。
The standard stipulates that the retention time of the main peak in the chromatogram of the test solution should be consistent with the retention time of the main peak in the chromatogram of the reference solution.

6．3．山梨糖醇含量  6.3. Sorbitol content
6．3．1．试剂和试液   6.3.1. Reagents and test solutions
水：符合 GB／T6682 的一级水。   Water: Grade 1 water in accordance with GB/T6682.
山梨糖醇标准样品：质量分数

⩾ 98.0 %

。
Sorbitol standards: mass fraction

⩾ 98.0 %

6．3．2．仪器和用具 6.3.2. Instruments and utensils

高效液相色谱仪；色谱柱；示差折光检测器；电子天平； 50 ml 量瓶。
high-performance liquid chromatograph; Columns; Refractive index detector; electronic balances; 50 ml measuring flask.

6．3．3．色谱条件 6.3.3. Chromatographic conditions

色谱柱：以钙型强酸性阳离子交换树脂为填充剂专用于糖及糖醇的分析柱，柱长 300 mm ，柱内径 7.8 mm ，或其他等效色谱柱。
Columns: Analytical columns with calcium-type strong acidic cation exchange resin as filler for sugar and sugar alcohols, with a column length of 300 mm and a column inner diameter of 7.8 mm, or other equivalent columns.

流动相：蒸馏水；流速：

0.8 ml / \min

；柱温：

80^{\circ} C

，并控制温度波动不得超过

1^{\circ} C

；进样量：

20 μ l

。
Mobile phase: distilled water; Flow Rate:

0.8 ml / \min

; Column temperature:

80^{\circ} C

, and control the temperature fluctuation shall not exceed

1^{\circ} C

; Injection volume:

20 μ l

6．3．4．测定 6.3.4. Determination

对照品溶液的制备：称取 2.5 g 山梨糖醇对照品，精确至 0.0002 g ，于 50 ml 容量瓶中，加流动相溶解，稀释定容至刻度，混匀。色谱分析前用

0.45 μ m

微孔滤膜过滤。
Preparation of the reference solution: Weigh 2.5 g of sorbitol reference substance, accurate to 0.0002 g, dissolve in a 50 ml volumetric flask, add mobile phase to dissolve, dilute to the scale, and mix well. Filtration with

0.45 μ m

microporous membranes before chromatographic analysis.

供试品溶液的制备：称取 2.5 g 供试品，精确至 0.0002 g ，于 50 ml 容量瓶中，加流动相溶解，稀释定容至刻度，混匀。色谱分析前用

0.45 μ m

微孔滤膜过滤。
Preparation of test solution: weigh 2.5 g of test sample, accurate to 0.0002 g, dissolve in a 50 ml volumetric flask, add mobile phase to dissolve, dilute to the scale, and mix well. Filtration with

0.45 μ m