JJF 1449-2014 English PDF

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JJF 1449-2014: Calibration Specification for Disintegration Analyzers
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
JJF 1449-2014	369	Add to Cart	3 days	Calibration Specification for Disintegration Analyzers	Valid

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Basic data

Standard ID: JJF 1449-2014 (JJF1449-2014)
Description (Translated English): Calibration Specification for Disintegration Analyzers
Sector / Industry: Metrology & Measurement Industry Standard
Classification of Chinese Standard: A61
Classification of International Standard: 17.020
Word Count Estimation: 16,149
Date of Issue: 2/14/2014
Date of Implementation: 5/14/2014
Quoted Standard: JJF 1094-2002; People's Republic of China Pharmacopoeia
Regulation (derived from): ?AQSIQ Announcement 2014 No. 17
Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine
Summary: This Standard applies to the determination of the performance of disintegration disintegration tester (hereinafter referred to disintegration tester) calibration.

JJF 1449-2014: Calibration Specification for Disintegration Analyzers

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Calibration Specification for Disintegration Analyzers People's Republic of China National Metrology Technical Specifications Disintegration tester calibration specification Issued on. 2014-02-14 2014-05-14 implementation The State Administration of Quality Supervision, Inspection and Quarantine released Disintegration tester calibration specification zers Focal point. the National Technical Committee stoichiometric physical Main drafting unit. Liaoning Provincial Institute of Metrology Tianjin Tianda Tianfa Technology Co., Ltd. Participated in the drafting unit. Tianjin Institute of Supervision and Testing Weighing Jilin Institute of Metrology This specification stoichiometric commissioned National Technical Committee is responsible for the physical interpretation The main drafters of this specification. Aiming Ze (Liaoning Provincial Institute of Metrology) Xiao Zhe (Liaoning Provincial Institute of Metrology) High Yucheng (Tianjin Tianda Tianfa Technology Co., Ltd.) Jin Yue-hong (Liaoning Provincial Institute of Metrology) Drafters participate. Weishu Long (Tianjin Supervision and Testing Institute of Metrology) Sun Air (Jilin Institute of Metrology)

table of Contents

Introduction (Ⅱ) 1 Scope (1) 2. References (1) 3 Overview (1) 4 Metrological characteristics (1) Basket moves up and down from the 4.1 maximum permissible error (1) 4.2 Disintegration Tester basket roundtrip frequency maximum permissible error (1) 4.3 relative timing error of the timer (1) 4.4 Temperature maximum permissible error (2) 4.5 indication error and repeatability (2) Calibration Condition 5 (2) 5.1 Calibration Environment (2) 5.2 standard devices and other equipment (2) 6 calibration items and calibration methods (2) 6.1 Calibration before the test (2) Basket moves up and down from the 6.2 maximum permissible error (2) 6.3 Disintegration Tester basket roundtrip frequency maximum permissible error (2) 6.4 Timer timing relative error (3) 6.5 The maximum allowable temperature error (3) 6.6 Indication error (3) 6.7 Repeatability (3) 7 Calibration Results (4) 8 Recalibration interval (4) Appendix A recommended calibration record format (5) Appendix B Calibration Certificate page format recommended (7) Appendix C Evaluation of Uncertainty in Measurement Example (8)

Introduction

This specification is based on JJF 1071-2010 "National Calibration Specifications writing rules", JJF 1001 "general purpose Volume terms and definitions ", JJF 1059" Evaluation and Expression of Uncertainty in Measurement ", and referring to People's Republic of China Pharmacopoeia (2010 edition, Appendix XA) provisions have been made. This specification calibrated main items are. --- Basket moves up and down from the maximum permissible errors; --- Basket roundtrip frequency maximum permissible error; --- Timer timing relative error; --- Temperature maximum permissible error; --- Indication error and repeatability. The specification for the first time to develop. Disintegration tester calibration specification

1 Scope

This standard applies to the determination of the disintegration performance disintegration tester (hereinafter referred to as disintegration tester) calibration. 2. References This specification references the following documents. JJF 1094-2002 measuring instrument characteristics evaluation People's Republic of China Pharmacopoeia (2010 edition two Appendix XA) For dated references, only the dated edition applies to this specification; undated reference documents Member, the latest edition (including any amendments) applies to this specification.

3 Overview

Disintegration refers to oral solid dosage forms disintegrate under specified conditions all dissolved into scattered or crushed, or in addition to the insoluble coating material Broken capsule shell, shall all through the sieve. Disintegration Tester is based on the disintegration test method to measure solid preparation in Regulation Disintegration of the instruments under the given conditions. Disintegration Tester consists of bath, control systems, timing systems, metal stents can lift and lower the screen inlaid Basket, along with the composition of baffles and other components (see Figure 1).

1 a schematic diagram of Disintegration Tester

1- temperature sensor; 2 - control and timing system; 3 - can lift metal stents; 4- basket with mesh (with baffle); 5- bath

4 Metrological characteristics

Basket moves up and down from the 4.1 maximum permissible error The maximum permissible error. ± 2mm. 4.2 Disintegration Tester basket roundtrip frequency maximum permissible error The maximum permissible error. ± 3%. 4.3 Timer timing relative error ......

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