usp isopropyl alcohol monograph

1 USP has identified additional related monographs in the USP–NF and FCC, namely the USP Isopropyl Alcohol and USP Azeotropic Isopropyl Alcohol monographs, and the FCC Ethyl Alcohol and FCC Isopropyl monographs. Expert Committee: (EM105) Excipient Monographs 1. Cool to room temperature, add 300 mL of isopropyl alcohol, dilute with water to volume, and mix. 0 ITEM# P025IP99. USP Reference standards 11 — USP Denatonium Benzoate RS. Pharmacopeial Forum: Volume No. * / USP* / LSM 057 The material meets all requirements of USP* Monograph “Isopropyl Rubbing Alcohol”** Product code: 057 Parameter USP* Additional Parameters Specification Test method Specification Test method %%EOF Specific gravity 841 : between 0.8691 and 0.8771 at 15.56 (the U.S. Government standard temperature for alcohol determination), for Rubbing Alcohol manufactured with specially denatured alcohol Formula 23-H. Isopropyl Alcohol (IPA) 99%, USP. Assay— Inject about 5 µL of Isopropyl Alcohol into a suitable gas chromatograph, equipped with a thermal conductivity detector. USP Reference standards 11 — USP Dehydrated Alcohol RS. Arrange the flask for distillation, distil, and collect 95 mL of distillate in a 100-mL volumetric flask. Quality Provided proper storage and handling precautions are taken we would expect Isopropyl Alcohol-USP to be technically stable for at least 12 months. h�bbd``b`�$V Ə@��H����AL��� YF���� �� x��W�r�6}�WФ"J X LHE�%��j�m��I�������.o2���f4$�سg�7RB�C���IF��k�V�i.Oz�Y�/DR��s�S. does not include isopropyl alcohol. Home; ISOPROPYL ALCOHOL - 2014-02-01. The preparation may be colored with one or more color additives, listed by the FDA for use in drugs. endstream endobj startxref Category: Lab Solvents, Process Solvents, Solvents: Attribute(s) Anhydrous, Conflict Free, GMO Free, High Purity: Packaging : 4x4L Case - ITEM# P016IP99 25 L Pail - ITEM# P025IP99 210 L Steel Drum - ITEM# P210IP99 ITEM# P1000IP99. Rubbing Alcohol contains, in each 100 mL, not less than 355 mg of sucrose octaacetate or not less than 1.40 mg of denatonium benzoate. USP has identified additional related monographs in the USP–NF and Food Chemicals Codex (FCC), namely the USP Isopropyl Alcohol, USP Azeotropic Isopropyl Alcohol, FCC Ethyl Alcohol, and FCC Isopropyl Alcohol monographs. Pending Monographs; Purchase USP–NF. ff4308f7-9d1b-fa31-c3dc-2c24219cb048. %PDF-1.5 %���� Isopropyl alcohol 70% (V/V) ≈ Isopropyl alcohol 62.8% (m/m) Testing specifications: Ph. A suitable stabilizer may be added. Line 17 of Chromatographic system: Change 1 0 obj << /Type /Catalog /Pages 2 0 R /PageMode /UseNone /ViewerPreferences << /FitWindow true /PageLayout /SinglePage /NonFullScreenPageMode /UseNone >> /Metadata 44 0 R >> endobj 2 0 obj << /Type /Pages /Kids [ 8 0 R 18 0 R 22 0 R ] /Count 3 /MediaBox 3 0 R /CropBox 4 0 R >> endobj 3 0 obj [ 0 0 595 841 ] endobj 4 0 obj [ 0 0 595 841 ] endobj 5 0 obj << /Length 1472 /Filter [ /FlateDecode ] >> stream %PDF-1.4 %���� ITEM# P016IP99. The pH of the resulting solution is between 5.0 and 5.5. USP29–NF24 Page 68. » Rubbing Alcohol and all preparations under the classification of Rubbing Alcohols are manufactured in accordance with the requirements of the U.S. Treasury Department, Bureau of Alcohol, Tobacco, and Firearms, Formula 23-H (8 parts by volume of acetone, 1.5 parts by volume of methyl isobutyl ketone, and 100 parts by volume of ethyl alcohol) being used. Rubbing Alcohol complies with the requirements of the Bureau of Alcohol, Tobacco, and Firearms of the U.S. Treasury Department. Under typical conditions, the gas chromatograph contains a 1.8-m × 6.4-mm (OD) stainless steel column packed with 10% liquid phase G20 on support S1A, the column is maintained at 55, and helium is used as the carrier gas at a flow rate of 45 mL per minute. 3. Unless otherwise specified, and consistent with USP and FCC monographs, references in this guidance to “alcohol” refer to ethanol. USP–NF Spanish Edition; USP–NF Archive Products; USP–NF Mobile App; Online FAQs; Breadcrumb. It contains not less than 68.5 percent and not more than 71.5 percent by volume of dehydrated alcohol, the remainder consisting of water and the denaturants, with or without color additives, and perfume oils. Standard solution— Dissolve an accurately weighed quantity of USP Phenoxyethanol RS in Phenol solution to obtain a solution having a known concentration of about 5 mg of phenoxyethanol per mL. h�b```f``�``b``cd�g@ ~0�p``P�S����#�̭�{����-��L�(�٭����^� �� Where the denaturant is denatonium benzoate—, Where the denaturant is sucrose octaacetate—. USP will announce potential compendial revisions to these monographs at a later date. Monograph Title. endstream endobj 949 0 obj <. B&�q��j��&3�6;n_��«���LWp0dt0Ht0� G�`� 38: (����t�1�Z ���f������&�iF�$ m��4c>�fg`��L,���+ӕ$�2�(� �E$ Accurately transfer 500 µL of this solution to a vial, add 1000 µL of isopropyl alcohol, crimp the vial, and mix on a vortex mixer for about 15 seconds. ITEM# P210IP99. Eur. Errata Identifier . 954 0 obj <>/Filter/FlateDecode/ID[<35C92EA38E168A468A674C84274FB223><4C9E76A8CD962E4FA8B8434B9D660975>]/Index[948 15]/Info 947 0 R/Length 53/Prev 185788/Root 949 0 R/Size 963/Type/XRef/W[1 2 1]>>stream ISOPROPYL ALCOHOL 99% Meets REAGENT ACS/USP/NF GRADE Monographs Main Catalog #: 231000099-Size Code*, zp231000099-Size Code* Alternate Catalog #: zc2310000CP-Size Code* Available in the following sizes: *Refer to Master Price List – Individual package sizes have unique size codes PRODUCT SPECIFICATIONS MONO GRAPH LIMITS TYPICAL RESULT 948 0 obj <> endobj 962 0 obj <>stream Assay— Transfer 50.0 mL of Isopropyl Rubbing Alcohol to a 250-mL distilling flask, and add 100 mL of water. Isopropyl Alcohol-USP does not contain detectable quantities of polycyclic aromatics, heavy metals or chlorinated compounds. alcohol. For detailed ISOPROPYL ALCOHOL.

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