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be made in each case in order to ensure that the provisions of any such law are being complied with. In general, the Drugs and Cosmetics Act, 1940, the Narcotic Drugs and Psychotropic Substances Act, 1985, the Poisons Act, 1919 and the rules framed thereunder should be consulted. These statutes empower the Government a... |
ion traditional system ofdrugs were limited. However, most of the ~ has‘beenteceiving significant inputs fromregulatory, industrial - new drugs manufactured and/or marketed were included, while houses, academic institutions, national laboratories, individual only those herbal drugs which had definitive quality control ... |
s on antiretroviral, anticancer, antituberculosis and herbal drugs. It further emphasized on biological monographs suchas Vaccines, Immunosera for Human use, Blood products, Biotechnological and Veterinary (Biological and nonbiological) preparations. Addendum 2008 to the IP 2007 was published which had taken care of th... |
the IPC, besides following the website of the IPC, besides following website of the IPC, besides following of the IPC, besides following the IPC, besides following IPC, besides following besides following following conventional approach of obtaining comments. approach of obtaining comments. of obtaining comments. obtai... |
es; Drug Substances, Dosage ba Forms and Pharmaceutical Aids (N to Z); Vaccines and Immunosera for Human Use; Herbs and Herbal Products; Blood and Blood-related Products; Biotechnology Products; Veterinary Products and Index. The Standards prescribed in the Indian Pharmacopoeiaare The IPC Secretariat and Indian Pharmac... |
he Chief Scientific and Executive Officer of the . . . Commission, . to deleting obsolete ones and amending those requiring upgrading /revision.
- e ‘To take note of the the different levels of sophistication sophistication in analytical testing/ instrumentation available while framing testing/ instrumentation ava... |
dients, pharmaceutical aids and Nirman Bhawan Bhawan dosage forms as well as medical devices, and to keep New Delhi -110011. Delhi -110011. -110011. 7 them updated updated by revision on aregular basis. (Mr. Naved Masood) Masood)
- e To develop monographs for herbal drugs, both raw drugs Member The Joint Secretary (D... |
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|The General Body|20th KM, Hosur Road|
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|Chairman|The Secretary (Health & Family Welfare)|Member|Professor B.|Suresh|
|(ex-officio)|| Gover... |
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|(IDMA)|Member|Dr. Prem|K. Gupta|
|102-B, Poonam Chambers,|‘A’ Wing’|Ex-Drugs Controller (1)|
|Dr. Annie Besant Road, Worli|House No. 95 DDA Flats|
|Mumbai— 400018.|;|Pocket|‘B’, Sukhdev Vihar|
|(Mr. N.R.;|Munjal)|NewowesDelhi -110 025.|||
|Member|.|Member|Prof. Y. K. Gupta|
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||DepartmentofPharmaceuticalAnalysis<br>National Institute ofPharmaceutical Education||||ExpertCommitteeonAnti-RetroviralDrugs||||
||andResearch(NIPER)||||Dr.ManishGangrade(Chair), Mr.Anwar,Dr.PramodDalvi,||||
||Sector67,<br>SASNagar||||Mr.AntonyRajGomesandDr.Heman... |
istry Division B.N. Thakore. The team contributed on works related other than biological Expert Committee on Herbal Products and CrudeDrugs monographs: Dr. D. B. Anantha Narayana (Chair), Dt. Amit Agarwal, Dr.c, _D® Anil Kumar Teotia, Dr. Robin Kumar, Ms. Sangeeta K.NEKativar, Mr. Ramakant Haralakha and Dr. Georse Pata... |
e D’souza Mr. K. S. Dubal Mr. Mahendra Durgavale Prof. Brijesh Chandra Gautam Mrs. Aboli Girena Dr. Bala Gopalnair Mr. Prasun Guha Mr. Sanjay Gupta Dr. 8. K. Gupta Mr. D. S. Gupte Mr. Ranga Iyer Dr. R. K. Jadhav Mr. R. S. Jadhav. Dr. D.C. Jain Dr. Ravi Jain Mr. Nilesh Jha Dr, Sadhna Joglekar Mr. Dharmin Joshi Ms. Neeta... |
. C. R. Wani Dr. 8S. S. Yadav
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## Acknowledgements
In preparing the sixth edition of the Indian Pharmacopoeia Macleods Pharmaceuticals, Mumbai and the Indian 2010, the Bri... |
apacity Laboratories, Gurgaon; Baxter (india) Pvt. Ltd., Gurgaon; motivated one and all in their efforts to give oftheirbest for Central Institute of Medicinal & Aromatic Plants, Lucknow: the creation of this compendium. The Commission is indebted Cipla Ltd., Mumbai; Arbro Pharmaceutical Ltd., New Delhi; to him. Hindus... |
s and and ut ‘8 inculcate on the manufacturer fo ensure that the Cosmetics Act. 1940. article is manufactured in accordance with the Good , Manufacturing Practices (GMPs). It is essential that : sufficiently stringent limits are applied at the time of release of Presentation a batch of a drug substance or drug product ... |
Related substancos tests are upgraded chapter on NMR is incorporated in Appendices. The by liquid chromatography method in view to have more chapter me : Serer specificity and to harmonise with other International great extenton microbialto harmonisecontaminationwith prevailingis also updatedinternationalto a Pharmacop... |
the microbiological. ; quality, the whole Betamethasone Lotion: . ws os i Betamethasone Ointment microbiological general chapter comprising of effectiveness } of antimicrobial preservatives, microbial contamination in Bifonazole . nonsterile products and microbiological quality ofraw material, Bifonazole Cream dosage f... |
Fluorescein Injection - Menthol and Benzoin Inhalation - | , DicloxacillinOralSuspension Flutamide "Metformin Hydrochloride SustainedDiethanolamine 7 a, Flutamide Capsules... es > release Tablets / | | Dihydroergocristine Mesylate _ Fumarjc Acid « PENS ek ag — Methadone Linctus _— a 7 Dihydroergotamine Mesylate .... - ... |
venous Infusion Temozolomide Capsules Belladonna Tincture Poloxamers Terazosin Hydrochloride Bhibhitaki Aqueous Extract Polyoxyl 35 Castor Oil Thiocolchicoside Brahmi Extract Polyoxy!l 40 Hydrogenated Castor Oil Thiocolchicoside Capsules Coconut Oil Potassium Sorbate Ticarcillin and Clavulanic Acid Coleus Dry Extract P... |
idogrel Tablets hee Tab Azithromycin Tablets Clotrimazole Cream Bacitracin Cresol with Soap Solution . Ketoprofeneneae © tablets Bacitracin Zinc Cytarabine Ketoprofen Capsules Benzyl alcohol Danazoly Lactose. . . Levamisole Tablets Bromhexine Hydrochloride Danazol Capsules ons . ‘ Levocitrizine Hydrochloride Bromhexine... |
ate Sulphacetamide Sodium Inactivated Pentamidine Isethionate Sulphacetamide Eye drops Fowl Cholera Vaccine, Inactivated Pentamidine Injection Talc Fowl Pox Vaccine, Live Pethidine Hydrochloride Terbutaline Tablets Inclusion Body Hepatitis (BH) Pethidine Injection Theophylline Vaccine, Inactivated Phenolphthalein Theop... |
ture text -----**<br>
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|---|---|---|---|---|---|---|---|
|CONTENTS|||
|VOLUMET|
|Notices|bees|Vv|
|Preface|bene|Vil|
|Indian Pharmacopoeia Commission|bene|ix|
|Acknowledgements|bees|xv|
|.|Introduction|bene|XVil|
|.|
|General Chapters|bese|7|
|VOLUME II|
|General Notices|sense|711|
|General Monographs on Dosag... |
cription|||seve||14||||
||Solubility|||oe||14||||
||TestMethods|||sess||14||||
||Identification|.||bese||14||||
9
7
|
.
## 1. GENERAL NOTICES
## INDIAN PHARMACOPOEIA 2010
||Tests and Assays||SA|fe|||es|||—|14||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
||Tests|||||a|||=||—|14|||
||OtherTests|... |
ble substances may be and other specifications is binding wherever deviations from added to an official preparation to enhance its stability, the General Notices exist. Likewise, where there isno specific usefulness or elegance, or to facilitate its preparation. Such mention to the contrary, the General Notices apply. ... |
ocedure given in this Pharmacopoeia is monographs apply to articles that are intended for medicinal conclusive.
11
1, GENERAL NOTICES
IP 2010 .
Meanings ofTerms So oo — percent v/v (percentage, volume in volume) expressing Alcohol. The term “alcohol” without qualification means the number of millilitres of subs... |
equirements of the monograph on Purified Water. product, feeistlled water indicates Purified Water prepared by Usually, the strength of solutions of solids in liquids is , expressed as percentage weight in volume, of liquidsin liquids Temperature. The symbol ‘” used without qualification as percentage volume in volume,... |
n the general Monographs Titles.monographs. The main title for a drug substance is the International General Monographs Non-proprietary Name (INN) approved by the World Health Organization. Subsidiary names and synonyms have also been General monographs on dosage forms include requirements given in some cases; where in... |
s specified, is specified, specified, An article described in a monograph of the Pharmacopoeia is article described in a monograph of the Pharmacopoeia is described in a monograph of the Pharmacopoeia is in a monograph of the Pharmacopoeia is a monograph of the Pharmacopoeia is monograph of the Pharmacopoeia is of the ... |
onograph of the Pharmacopoeia is of the Pharmacopoeia is the Pharmacopoeia is Pharmacopoeia is is the International Union of Pure and Applied Chemistry to be manufactured in accordance with the principles of be manufactured in accordance with the principles of in accordance with the principles of accordance with the pr... |
he statement is given in terms of the principal and are intended as information on the approximate solubility ingredient(s). Ps . _ ata temperature between 15° and 30°, unless otherwise stated, In monographs on vegetable drugs, the definition indicates 04 arenot tobe considered as official requirements. However, whethe... |
the Pharmacopoeia depend. The requirements The medical practitioner will exercise his own judgment and are not framed to take into account all possible impurities. Itis act on his own responsibility in respect of the amount of any not to be presumed, for example, that an impurity that is not therapeutic agent he may pr... |
ent and the quantity chapters showing their nature, degree of purity and the of the preparation to be taken are calculated from the strength strengths of the solutions to be made from them. The stated on the label. . requirements set out are not intended to imply that the materials Other Tests. In the monographs on dos... |
vals Quantities are weighed or measured with an accuracy : commensurate with. the indicatedge degree of precision... For against the Reference Substances weighings, the precision is plus or minus 5 units after the last Biological Reference Substances, also abbreviated to IPRS figure stated. For example, 0.25 gis to be ... |
ight are indicated, where appropriate, in the individual by extraneous solids, liquids or vapours and from loss of the monograph. article under normal conditions of handling and storage. | ae Lo, . Where, additionally, loss or deterioration of the article from Specific directions are given i some monographs with Tespec... |
available compressor oils, it is Gas detector tubes are cylindrical, sealed tubes consisting of thenecessary oi used. to verifyInformation the reactivityon the reactivity of the oil detector tubesfor various oils foris an inert transparent material and constructed to allow the given in the leaflet supplied with the tub... |
mum value indicated is 5 ppm or less, with a relative indicator tube to the short leg of the tubing and operate the Standard deviation of not more than + 15 per cent. | pump by the appropriate number of strokes to pass a suitable Hydrogen sulphide detector tube: Sealed glass tube containing volume of the gas under exam... |
lamp. A suitable filter may be fitted to eliminate the<br>sizemm size -tmm visible part of the spectrum emitted by the lamp. Where the<br>4 55 40 0 136 monograph prescribes viewing under ultra-violet light of<br>8 . ot wavelength 254 nm or 365 nm, an instrument consisting of a<br>48 2.0 0.07 mercury vapour lamp anda fi... |
e highest accuracy. The<br>6274:1971, Method of Calibrating Liquid-in-Glass tolerances on capacity for volumetric flasks, pipettes and<br>Thermometers. The thermometers are of The thermometers are of thermometers are of are of of the mercury-in-glass mercury-in-glass burettes, as laid down in the relevant Indian Stand... |
05 0.05 0.1 0.1 c Tolerance, + ml Class A 0.01 0.03 0.05 0.1 : Bd faa Class B 0.02 0.06 0.1 0.2 Where it is directed that a quantity be ‘accurately measured’, A the apparatus must be chosen and used with care. A burette should be of such size that the titrant volume represents not ; B less than 30 per cent of the nomin... |
.9.|Microbial Contamination in Nonsterile Products|sees|37|
|2.2.10.|Microbiological Assay ofAntibiotics|bees|49|
|2.2.11.|Sterility|bene|56|
|2.2.12.|Thiomersal|bees|63|
|2.2.13.|Urinary Excretion ofDextrans|bane|64|
|2.2.14.|Immunochemical Methods|bese|64|
|2.2.15.|Host-cell and Vector-derived DNA|wei|66|
|2.2.16.|Li... |
test, there of the animals die or show signs of ill health, repeat the test. is a significant fall or no increase in the number of The preparation passes the test if none of the animals in the microorganisms in the inoculated preparation after storage ‘second group dies or show signs of ill health in the time interval ... |
gh recognized that the presence of dead microorganisms or their concentration of sugar.
27
2.2.2, EFFECTIVENESS OF ANTIMICROBIAL PRESERVATIVES
IP 2010
In order to prevent any phenotypic changes in the strains used, the organisms used in the test should not be more be more more than 5 passages made from the orig... |
seline to Concentration of bacterial bacterial use in the test. the sample or on on the article to which
by pour plate method pour plate method plate method method or filtration method. This value serves The test for bacterial endotoxins (BET) measures the to determine the inoculum concentration and the baseline to C... |
n terms of percentage of initial concentration. Method C. Kinetic Turbidimetric Method Interpretation. The preservatives are considered to be Method D. Kinetic Chromogenic Method i) For parenteral, ophthalmic, sterile nasal and otic Whenamonograph includes atestfor bacterial endotoxins without preparations: (a) the con... |
ve result under the conditions prescribed in the test for bacterial endotoxins on the preparation under examination. It may be prepared by distilling water three times in an apparatus fitted with an effective device to prevent the entrainment of droplets of droplets droplets or by by other means means that give water o... |
rd endotoxin. Ge}-Clot Methods The Endotoxin Reference Standard (ERS) is the freeze-dried, . purified endotoxin of Escherichia coli, which is calibrated in Methods Aand B depend on the formation of a firm gel when Endotoxin Units (EU) by comparison with the International a solution containing bacterial endotoxins is in... |
on at or below consisting of water BET. At least the final dilution in each MVD (test solution). i series must give a negative result. Solution B = Test solution spiked with indicated CSE Calculate the average of the logarithms of the lowest concentrations (Positive Product Control; PPC). concentration of endotoxin in ... |
geometric mean end-point concentration of r solutions of series B and C by using the formula described where, A is the labelled sensitivity of the lysate (EU/ml). under Sensitivity of the lysate. * Concentration of the test solution is expressed as mg/ml in case the Calculation and interpretation of results. The test f... |
btained at 0.25 MVD and | was equal to 0.125 EU/ml, interference without removing endotoxins by repeating the . ar : . test . : : : the endotoxin concentration in the test solution will be for interfering factors using the preparation under 8x 0.25 x 0.125 =0.25 EUMml examination to which the CSE has been added and whi... |
used by the reaction of repeated[as] and[described] a negative[above.] result[The] for[ results] the other,[of][ the] the[ retest] test[ should] may be isthea methodendotoxin with measuringthe lysate.either The the timeKineticturbidimetric(onset time) needed assayto be interpreted as for the initial test. reach a prede... |
e interfere with the test. h tonto eer tactwe 1s beyon 4 . TE © voderg The validation must be repeated if the lysate vendor or the i c “ hande eG reat M, hod y the procedure method of manufacture or formulation of the sample is escribed under the Gel-Clot Method. changed. The initial dilution may be prepared using the ... |
UBSTANCES
## Method E. End-Point Chromogenic Method
## Test Animal
Preparation of test solutions. Unless otherwise prescribed, Use a healthy, adult cat, either male or non-pregnant female, prepare the solutions to be employed in the test using water weighing not less than 2 kg. Weigh the cat and anaesthetise it B... |
tions of the dose of 0.1 tg solution from the standard curve. per kg are approximately the same and correspond to a decrease Interpretation of results. The assay is valid only if in pressure of not less than 20 mm of mercury. (a) the standard curve is linear for the range of CSE Method concentrations used; Dissolve the... |
depressor responses to the associate doses of the standard histamine solution represenDissolve the solid ingredients in 50 ml of distilled water by ting 0.1 ug of histamine per kg. warming on a water-bath. Add glycerin and sufficient distilled Ifgreater the depressor responsethan the mean to eitherof the depressor dose... |
tein — Jensen Medium : LJ Medium 2.2.5 Test for Colony Forming Units (CFU) a. Mineral salt solution The number of Colony Forming Units (CFU) must be Potassium; hydrogenyarogen Pphosphate, P (Bs(K,HPO) 24 g determined on the contents of at least 5 containers of the Magnesium sulphate (MgSO.) 0.24 g freeze-dried vaccine.... |
autions, mix 1 volume of fresh group O serum free of lysins and 1 volume thoroughly, distribute 5-ml aliquots into 25-ml McCartney of a 10 per cent v/v suspension, in saline solution, of A; or B bottles and screw on the caps tightly. Lay the bottles corpuscles (whichever were lysed in the first test). At the horizontal... |
orresponding to the maximum: tolerated in the Water _ monograph and note whether the contractions produced by for injections to 1000 ml the preparation with the added histamine correspond to the Solution 2 should be freshly prepared and used within amount of histamine added. If this is not the case, or if the 24 hours.... |
dose. Flush the organ bath a rabbit has been given a test substance that was adjudged 3 times with solution 2 before each addition of histamine. The pyrogenic, at least 2 weeks must be allowed to elapse before successive additions should be made at regular intervals the animal is used again. allowing a complete relaxat... |
that a maximum reading is reached in less the “initial temperature” and the “maximum temperature” than 5 minutes. Insert the thermometer or temperature-sensing which is the highest temperature recorded for a rabbit is taken probe into the rectum of the test rabbit to a depth of about © be its response. When this differ... |
3 hours after the injection. Not more than These tests are not applicable to product containing viable 40 minutes immediately preceding the injection of the test microorganisms as active ingredients. thedose, = recorreconene“initi remperatines vor”hovecn abeit, chwhich .i Alternative. microbiological procedures, includ... |
the standardized inoculum by a factor greater as inoculation and growth of the organisms from existing gan 2 or should be comparable to that obtained on the same culture to a fresh medium. medium previously tested and approved. Grow each of the bacterial test strains separately in Casein soyabean digest broth (Medium 1... |
Casein soyabean digest broth (Medium 1) _ specified, with 5 g of sterile polysorbate 20 or polysorbate with not more than 100 CFU of each of the three above 80. If necessary, heat to not more than 40°. Mix carefully
38
2.2.9, MICROBIAL CONTAMINATION IN NONSTERILE PRODUCTS
IP 2010 2.2.9, MICROBIAL CONTAMINATION IN... |
gauze | Microbicidal property of the product and the product is not and transfer them to a suitable volume of buffered sodium _ likely to be contaminated with the microorganisms inoculated chloride-peptone solution pH 7.0 containing inactivator such Ut can contain other organisms. Then carry out the tests as polysorbat... |
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