GB 1790-1994Medicinal vaseline (English PDF)

Foreword

The standard Chapter 6, Chapter 7 (except for test methods) are mandatory, the rest are recommended.

This standard was drafted in accordance with GB/T 1.1-2009 given rules.

This standard replaces GB 1790-2003 "medicine Vaseline." The main differences between this standard and GB 1790-2003 are as follows.

--- Added "Terms and Definitions", "characteristics" and "recognition" chapter (see 5 and 6);

--- Increasing the "look" technical requirements (see 7);

--- Remove the "characters", "UV absorbance," "heterosexual organic" technical requirements (see the 2003 edition 4);

--- On the "dropping point", "penetration" and "sulfated ash" quality index has been modified (see 7, 2003 edition 4).

This standard uses redrafted law revision by the British Pharmacopoeia BP-2008 in the "white petrolatum", "yellow Vaseline" (in English) prepared. test Into account China's national conditions, when employing BP-2008, made some changes in this standard. This standard BP-2008 version of the main differences.

--- Increase the "scope", "normative references", "sample", "packaging, labeling, storage and delivery acceptance" and chapter;

--- The standard reference standard using our corresponding national standards and industry standards;

--- To increase the operability of the British Pharmacopoeia BP-2008 were refined, the British Pharmacopoeia BP-2008 version of "color" and "acid Alkalinity "test method as an appendix to this standard.

This standard by the National Standardization Technical Committee on Petroleum Products and Lubricants made.

This standard by the National Petroleum Products and Lubricants Standardization Technical Committee petroleum wax products Technical Committee (SAC/TC280 /SC3) centralized.

This standard was drafted. China Petroleum & Chemical Co., Ltd. Fushun Research Institute of Petroleum, Nanjing Chang Jiang Jiangyu petrochemical limited liability any company.

1 Scope

This standard specifies the definition of medicine Vaseline, classification, characteristics, identification, technical requirements and test methods, sampling, packaging, labeling, storage and Delivery and acceptance.

This standard applies to the petroleum fractions, refined obtained medicine Vaseline. This standard is applicable to the preparation of pharmaceutical products owned ointment and skin protection ointment.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.

GB/T 269 Lubricating grease and petrolatum Determination of cone penetration method (GB/T 269-1991, eqvISO 2137. 1985) GB/T 6040 General rules for infrared spectroscopy SH/T 0131 Petroleum waxes and petroleum grease sulphate - Determination of ash SH0164 petroleum product packaging, storage and delivery acceptance rules SH/T 0229 semi-solid and solid petroleum products - sampling method SH/T 0655 Test Method Vaseline polycyclic aromatic hydrocarbons SH/T 0678 Determination of dropping point Vaseline

3 Terms and Definitions

The following terms and definitions apply to this document.

White petrolatum whitesoftparaffin, whitepetroleumjely Semi-solid mixture is obtained from petroleum refining white more hydrocarbons. It can contain an appropriate antioxidant, this product does not fit for oral administration.

Yellow Vaseline yelowsoftparaffin, yelowpetroleumjely Semisolid mixture of hydrocarbons obtained from refined petroleum. It can contain an appropriate antioxidant, this product is not suitable for oral administration.

4 Products

The standard depth of their products by refining into white petrolatum and petrolatum two kinds of yellow.

5 Features

Table 1. Characteristics of medicine Vaseline.

Table 1 Characteristics of medicine Vaseline

Yellow Vaseline white petrolatum project Traits White or off-white, translucent, oleaginous ointments, after melting Sunlight showed a slight fluorescence Yellow, translucent, oily ointments, after melting showed a slight fluorescence daylight Solubility almost insoluble in water, ethanol and glycerol, slightly soluble in dichloromethane

6 Recognition

The primary identification. A, B, D;

Secondary identification. A, C, D.

A. Dropping Point

White petrolatum dropping point 35 °C ~ 70 °C, the label indicating the difference between the drop point is not more than 5 °C. Determination and installed according to SH/T 0678 Method Fill grease cup amended as follows. The test sample is heated to no more than 80 °C, stirring to ensure uniformity. The metal cup is heated to no greater than in the oven 80 °C.

Yellow Vaseline dropping point 40 °C ~ 60 °C, the label indicating the difference between the drop point is not more than 5 °C. Press SH/T 0678 Method Determination.

B. according to GB/T 6040 infrared spectra, and Vaseline typical infrared light absorption spectrum (see Appendix A) compared to its main Peak position and intensity of the infrared light absorption spectrum similar.

C. Take 2g sample was heated and melted, when a homogeneous mobile phase, and distilled water was added 2mL 0.2mL0.05mol/L iodine (iodine Preparation of solution. dissolve 13g of water with a small amount of iodine and potassium iodide 20g, add water to 1000mL, shake), shaken after cooling, the upper layer is a solid purple Pink (or light brown).

D. meet the technical requirements (see Table 2) the appearance requirements.

7 Technical requirements and test methods

Pharmaceutical Vaseline technical requirements and test methods are shown in Table 2.

2 medicine Vaseline technical requirements and test methods for tables project Quality Index Yellow Vaseline white petrolatum experiment method Exterior White, the color of melted not deeper than the reference solution A Yellow, the color of melted not deeper than the reference solution B Appendix B PH No Appendix C Dropping point/°C 35 ~ 70 40 ~ 60 SH/T 0678 Polycyclic aromatic hydrocarbons through by SH/T 0655 Penetration (150g, 25 °C) /0.1mm 60 ~ 300 100 ~ 300 GB/T 269 Sulfate ash (mass fraction) /% no greater than

0.05 SH/T 0131

8 Sampling

Sampling by SH/T 0229 carried 2.5kg taken as a test sample and stay with.

9 Packaging, labeling, storage and delivery acceptance

The product packaging, labeling, storage and delivery acceptance by SH0164 be stored away from light and marked drop point, use, add the oxidation Agent name and content.

Appendix A

(Normative)

Vaseline typical infrared spectrum Typical white, yellow Vaseline infrared light absorption spectra are shown in Figure A.1 and A.2.

Figure A.1 Typical white petrolatum infrared light absorption spectrum

Figure A.2 Typical yellow Vaseline infrared light absorption spectrum

Appendix B

(Normative)

Color Test Method

B.1 Scope

This appendix provides pharmaceutical vaseline color test.

This appendix applies to medicine Vaseline.

B.2 Method Summary

Load sample volume in flat-bottomed test tube, placed in a water bath to melt. Color samples were observed and compared with the reference liquid ratio.

B.3 Reagents and materials B.3.1 ferric chloride. AR.

B.3.2 cobalt chloride. AR.

B.3.3 concentrated hydrochloric acid. AR content (mass fraction) of 36% -38%, dubbed 2.5% (volume fraction) solution of dilute hydrochloric acid and 10g/L of Hydrochloric acid solution.

B.3.4 Sodium hydroxide. AR, dubbed 300g/L solution.

B.3.5 sulfuric acid. AR, dubbed sulfuric acid and water volume ratio of 1.4 dilute sulfuric acid solution.

B.3.6 sodium thiosulfate. AR, dubbed 0.1mol/L standard solution.

B.3.7 hydrogen peroxide. dubbed 3% (volume fraction) of a dilute solution.

B.3.8 soluble starch. AR, dubbed 1.0% (mass fraction) solution.

B.3.9 KI. AR.

B.3.10 distilled water.

B.4 instruments and equipment B.4.1 tube. flat, colorless, transparent, neutral glass tube, an inner diameter of 15mm ~ 25mm.

B.4.2 conical flask. 250mL, with a ground plug.

B.4.3 flask. 1000mL.

B.4.4 pipette. 5.0mL, 10.0mL, 25.0mL.

B.4.5 beaker. 100mL.

B.4.6 cylinder. 100mL.

B.4.7 Buret. 25mL.

B.4.8 balance.

B.5 preparation of reference solution B.5.1 yellow basic solution (0.1667mol/LFeCl3 · 6H2O solution) B.5.1.1 preparation. Weigh 46g of ferric chloride (FeCl3 · 6H2O), adding about 900mL2.5% (volume fraction) was dissolved in dilute hydrochloric acid, Continue to add, and volume 1000 mL. Titration and dilute hydrochloric acid solution to adjust the above, the yellow liquid containing 45.0 mg per ml FeCl3 · 6H2O. Stored.

B.5.1.2 titration. with grinding mouth in a plug 250mL conical flask, add 10.0mL yellow solution, 15mL water, 5mL concentrated salt 4g acid and potassium iodide, stuffed with cork, placed in the dark 15min, plus 100mL water. Sodium thiosulfate standard solution 0.1mol/L of Titration of free iodine, when near the end of the titration add 0.5mL starch solution as indicator. 1mL0.1mol/L sodium thiosulfate standard solution Liquid equivalent 27.03mgFeCl3 · 6H2O.

B.5.2 red base solution (0.25mol/LCoCl2 · 6H2O solution) B.5.2.1 preparation. Weigh 60g cobalt chloride (CoCl2 · 6H2O), adding about 900mL2.5% (volume fraction) was dissolved in dilute hydrochloric acid, Continue to add, and volume 1000 mL. Titration and dilute hydrochloric acid solution to adjust the above, the red liquid containing 59.5 mg per ml CoCl2 · 6H2O.

B.5.2.2 titration. with grinding mouth in a plug 250mL conical flask, add 5.0mL red liquid, 5mL dilute solution of hydrogen peroxide and 10mL300g/L sodium hydroxide solution slowly boiled 10min, after cooling, 60mL sulfuric acid and 2g of potassium iodide, stuffed bottle Plug, slowly shaking Erlenmeyer flask to dissolve the precipitate completely. With 0.1mol/L sodium thiosulfate standard titration of free iodine in titration access Added 0.5mL starch solution as an indicator near the end point. Reach the titration end when the solution turned pink. 1mL0.1mol/L Sodium thiosulfate standard solution equivalent 23.79mgCoCl2 · 6H2O.

B.5.3 reference solution A. Before use directly from the basic solution preparation, 1.0 volume yellow basic solution (B.5.1.1) and 9.0 volume 10g/L mixture of hydrochloric acid solution.

B.5.4 reference solution B. prior to use directly from the basic solution preparation, 7.6 volume yellow basic solution (B.5.1.1) and 2.4 volume of red group the mixture solution (B.5.2.1) of.

B.6 Test procedure

B.6.1 12g of this product in a clean, dry, flat tube, melted in a water bath.

B.6.2 load the same volume of the same specifications of the flat tube reference solution, in natural light scattering, the molten sample and reference solution at the same time placed White background, vertical observation, comparison color.

B.7 Test results presentation with "deeper than" or "not deep in the" reference solution represents the color of the sample results.

Appendix C

(Normative)

PH Test Method

C.1 Scope

This appendix provides pharmaceutical Vaseline pH test.

This appendix applies to medicine Vaseline.

C.2 Method Summary

The sample was mixed with boiling water after shaking, the aqueous layer was cooled and filtered, the filtered aqueous solution successively dropping sodium hydroxide solution and phenolphthalein indicator Fluid, aqueous observe the color change to determine its pH.

C.3 Reagents and materials C.3.1 phenolphthalein indicator. Weigh 1.0g of phenolphthalein, was dissolved in ethanol (95%), diluted to 100mL with ethanol (95%).

C.3.2 Sodium hydroxide. AR, dubbed aqueous solution 0.01mol/L of.

C.4 instruments and equipment C.4.1 separating funnel. pear-shaped, 125mL.

C.4.2 tube. colorless glass, diameter 15mm ~ 20mm, high 140mm ~ 150mm.

C.4.3 qualitative filter paper.

C.4.4 pipette. 1.0mL, indexing 0.01mL.

C.4.5 beaker. 100mL.

C.4.6 cylinders. 10mL, 25mL.

C.5 Test Procedure

C.5.1 Weigh 10g (accurate to 0.1g) sample is placed in a clean, dry separatory funnel.

C.5.2 20mL of boiling distilled water was added to the separatory funnel has been called a good sample, the forced oscillation 1min, standing to cool layered with filter paper Filtration solution.

C.5.3 filtered aqueous solution of 10mL placed in a test tube, 0.1mL solution of phenolphthalein indicator, and then dropping up to 0.5mL 0.01mol/L sodium hydroxide solution, to observe the process of changes in the color of the aqueous solution.

Analyzing test results and presentation C.6 C.6.1 test results to determine Analyzing test results are shown in Table C.1.

Analyzing test results in Table C.1 Aqueous solution of phenolphthalein indicator color change color aqueous solution of sodium hydroxide solution and then change the test results no red toner unchanged no discoloration no discoloration sour Pink colored pink alkali C.6.2 test results presentation with "sour", "alkali" or "None" shows the results of pH tests.

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