USP General Chapter 41
2
Burets (Continued) Subdivisions, mL 0.02 0.1 0.1 Limit of error, mL 0.02 0.03 0.05 á41ñ BALANCES This chapter states the requirements for balances used for materials that must be accurately weighed (see General Noti- ces, 8.20). Unless otherwise specified, when substances must be “accurately weighed”, the weighing shall be performed using a balance that is calibrated over the operating range and meets the requirements defined for repeatability and accuracy. For balances used for other applications, the bal- ance repeatability and accuracy should be commensurate with the requirements for its use. For discussion of the theoretical basis of these require- ments, see general information chapter Weighing on an Ana- lytical Balance á1251ñ, which may be a helpful—but not mandatory—resource. REPEATABILITY Repeatability is assessed by weighing one test weight NLT 10 times. [NOTE—The test weight must be within the balan- ce's operating range, but the weight need not be calibrated. Because repeatability is virtually independent of sample mass within the balance's capacity, use of a small test weight, which may be difficult to handle, is not required.] Repeatability is satisfactory if two times the standard devi- ation of the weighed value, divided by the nominal value of the weight used, does not exceed 0.10%. If the standard deviation obtained is less than 0.41d , where d is the scale in- terval, replace this standard deviation with 0.41d . In this case, repeatability is satisfactory if two times 0.41d , divided by the nominal value of the weight used, does not exceed 0.10%. ACCURACY The accuracy of a balance is satisfactory if its weighing value, when tested with a suitable weight(s), is within 0.10% of the test weight value. A test weight is suitable if it has a mass between 5% and 100% of the balance's capacity. The test weight's maximum permissible error (mpe), or alternatively its calibration uncer- tainty, shall be NMT one-third of the applied test limit of the accuracy test. [NOTE—Applicable standards are the follow- ing: ASTM E617 (available from http://www.astm.org) and OIML R 111 (available from http://www.oiml.org).] Microbiological Tests á51ñ ANTIMICROBIAL EFFECTIVENESS TESTING Antimicrobial preservatives are sub stances added to non- sterile dosage forms to protect them from microbiological growth or from microorganisms that are introduced inad- vertently during or subsequent to the manufacturing proc- ess. In the case of sterile articles packaged in multiple-dose containers, antimicrobial preservatives are added to inhibit the growth of microorganisms that may be introduced from repeatedly withdrawing individual doses. Antimicrobial preservatives should not be used as a substi- tute for good manufacturing practices or solely to reduce the viable microbial population of a nonsterile product or control the presterilization bioburden of multidose formula- tions during manufacturing. Antimicrobial preservatives in compendial dosage forms meet the requirements for Added Substances under Ingredients and Processes in the General Notices . All useful antimicrobial agents are toxic subs tances. For maximum protection of patients, the concentration of the preservative shown to be effective in the final packaged product should be below a level that may be toxic to hu- man beings. The concentration of an added antimicrobial preservative can be kept at a minimum if the active ingredients of the formulation possess an intrinsic antimicrobial activ ity. Anti- microbial effectiveness, whether inherent in the product or whether produced because of the addition of an antimicro- bial preservative, must be demonstrated for all injections packaged in multiple-dose containers or for other products containing antimicrobial preservatives. Antimicrobial effec- tiveness must be demonstrated for multiple-dose topical and oral dosage forms and for other dosage forms such as ophthalmic, otic, nasal, irrigation, and dialysis fluids (see Pharmaceutical Dosage Forms á1151ñ). This chapter provides tests to demonstrate the effective- ness of antimicrobial protection. Added antimicrobial pres- ervatives must be declared on the label. The tests and crite- ria for effectiveness apply to a product in the original, unop- ened container in which it was distributed by the manufac- turer. PRODUCT CATEGORIES For the purpose of testing, compendial articles have been divided into four categories (see Table 1). The criteria of an- timicrobial effectiveness for these products are a function of the route of administration. G e n e r a l C h a p t e r s 52 á31ñ Volumetric Apparatus / Apparatus USP 37 fficia from ecember 1 201 o yri h c 2015 The ni ed S a es Pharmaco eia on en ion A ri h s reser ed Accessed from 10 6 1 10 by ProIndi7 on Thu Jan 15 07:25:00 EST 2015
description
USP General Chapter 41
Transcript of USP General Chapter 41
-
Burets (Continued)
Subdivisions, mL 0.02 0.1 0.1
Limit of error, mL 0.02 0.03 0.05
41 BALANCESThis chapter states the requirements for balances used for
materials that must be accurately weighed (see General Noti-ces, 8.20). Unless otherwise specified, when substances mustbe accurately weighed, the weighing shall be performedusing a balance that is calibrated over the operating rangeand meets the requirements defined for repeatability andaccuracy. For balances used for other applications, the bal-ance repeatability and accuracy should be commensuratewith the requirements for its use.
For discussion of the theoretical basis of these require-ments, see general information chapter Weighing on an Ana-lytical Balance 1251, which may be a helpfulbut notmandatoryresource.
REPEATABILITY
Repeatability is assessed by weighing one test weight NLT10 times. [NOTEThe test weight must be within the balan-ce's operating range, but the weight need not be calibrated.Because repeatability is virtually independent of samplemass within the balance's capacity, use of a small testweight, which may be difficult to handle, is not required.]
Repeatability is satisfactory if two times the standard devi-ation of the weighed value, divided by the nominal value ofthe weight used, does not exceed 0.10%. If the standarddeviation obtained is less than 0.41d, where d is the scale in-terval, replace this standard deviation with 0.41d. In thiscase, repeatability is satisfactory if two times 0.41d, dividedby the nominal value of the weight used, does not exceed0.10%.
ACCURACY
The accuracy of a balance is satisfactory if its weighingvalue, when tested with a suitable weight(s), is within0.10% of the test weight value.
A test weight is suitable if it has a mass between 5% and100% of the balance's capacity. The test weight's maximumpermissible error (mpe), or alternatively its calibration uncer-tainty, shall be NMT one-third of the applied test limit of theaccuracy test. [NOTEApplicable standards are the follow-ing: ASTM E617 (available from http://www.astm.org) andOIML R 111 (available from http://www.oiml.org).]
Microbiological Tests
51 ANTIMICROBIALEFFECTIVENESS TESTING
Antimicrobial preservatives are substances added to non-sterile dosage forms to protect them from microbiologicalgrowth or from microorganisms that are introduced inad-vertently during or subsequent to the manufacturing proc-ess. In the case of sterile articles packaged in multiple-dosecontainers, antimicrobial preservatives are added to inhibitthe growth of microorganisms that may be introduced fromrepeatedly withdrawing individual doses.
Antimicrobial preservatives should not be used as a substi-tute for good manufacturing practices or solely to reducethe viable microbial population of a nonsterile product orcontrol the presterilization bioburden of multidose formula-tions during manufacturing. Antimicrobial preservatives incompendial dosage forms meet the requirements for AddedSubstances under Ingredients and Processes in the GeneralNotices.
All useful antimicrobial agents are toxic substances. Formaximum protection of patients, the concentration of thepreservative shown to be effective in the final packagedproduct should be below a level that may be toxic to hu-man beings.
The concentration of an added antimicrobial preservativecan be kept at a minimum if the active ingredients of theformulation possess an intrinsic antimicrobial activity. Anti-microbial effectiveness, whether inherent in the product orwhether produced because of the addition of an antimicro-bial preservative, must be demonstrated for all injectionspackaged in multiple-dose containers or for other productscontaining antimicrobial preservatives. Antimicrobial effec-tiveness must be demonstrated for multiple-dose topicaland oral dosage forms and for other dosage forms such asophthalmic, otic, nasal, irrigation, and dialysis fluids (seePharmaceutical Dosage Forms 1151).
This chapter provides tests to demonstrate the effective-ness of antimicrobial protection. Added antimicrobial pres-ervatives must be declared on the label. The tests and crite-ria for effectiveness apply to a product in the original, unop-ened container in which it was distributed by the manufac-turer.
PRODUCT CATEGORIES
For the purpose of testing, compendial articles have beendivided into four categories (see Table 1). The criteria of an-timicrobial effectiveness for these products are a function ofthe route of administration.
Gen
eral
Ch
apte
rs
52 31 Volumetric Apparatus / Apparatus USP 37
Official from December 1, 2014Copyright (c) 2015 The United States Pharmacopeial Convention. All rights reserved.
Accessed from 10.6.1.10 by ProIndi7 on Thu Jan 15 07:25:00 EST 2015
![BRIEFING 797 Pharmaceutical Compounding—Sterile ... · BRIEFING 〈797〉 Pharmaceutical Compounding—Sterile Preparations, USP 41 page 6554 and PF 41(6) [Nov.–Dec. 2015]. Based](https://static.fdocuments.us/doc/165x107/5e5243085ae1a1195a452711/briefing-797-pharmaceutical-compoundingasterile-briefing-797-pharmaceutical.jpg)
