Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Detection method for calcitriol soft capsule production equipment cleaning verification

A detection method and production equipment technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve problems such as incompatibility, low content of active ingredients, and large damage to instruments

Inactive Publication Date: 2020-04-14
HENAN TAIFENG BIOTECH CO LTD
View PDF7 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the low content of active ingredients in calcitriol soft capsules (0.5 μg / capsule) and the incompatibility between medium-chain triglycerides and water, this method is difficult to operate and causes great damage to the instrument.

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Detection method for calcitriol soft capsule production equipment cleaning verification
  • Detection method for calcitriol soft capsule production equipment cleaning verification
  • Detection method for calcitriol soft capsule production equipment cleaning verification

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Prepare the test product according to the preparation process of the test product solution in the scheme, and take 100 μl into the chromatographic system. Chromatographic conditions: Chromatographic column: COSMOSIL 5SL-Ⅱ, 250mm×4.6mm, mobile phase: n-hexane: ethyl acetate: methanol: n-propanol = 60:40:2:1, UV detection wavelength is 265nm, flow rate is 1.2ml / min, column temperature: 30°C.

Embodiment 2

[0043] Prepare the test product according to the preparation process of the test product solution in the scheme, and take 100 μl into the chromatographic system. Chromatographic conditions: Chromatographic column: COSMOSIL 5SL-Ⅱ, 250mm×4.6mm, mobile phase: n-hexane: ethyl acetate: methanol: n-propanol = 60:40:2:1, UV detection wavelength is 267nm, flow rate is 1.2ml / min, column temperature: 30°C.

Embodiment 3

[0045] Prepare the test product according to the preparation process of the test product solution in the scheme, and take 100 μl into the chromatographic system. Chromatographic conditions: Chromatographic column: COSMOSIL 5SL-Ⅱ, 250mm×4.6mm, mobile phase: n-hexane: ethyl acetate: methanol: n-propanol = 60:40:2:1, UV detection wavelength is 263nm, flow rate is 1.2ml / min, column temperature: 30°C.

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

The invention provides a detection method for calcitriol soft capsule production equipment cleaning verification. The method comprises: step A, wiping the surface of to-be-detected equipment by usinga cotton swab, arranging a sample wiping cotton swab in a container, adding absolute ethyl alcohol, and sequentially carrying out ultrasonic treatment and filtration to obtain a test product solution;and step B, injecting the test solution into a chromatographic system and carrying out detection. The chromatographic system comprises a liquid chromatograph and an ultraviolet detector; the chromatographic detection conditions are as follows: a chromatographic column is filled with high-purity silica gel, a mobile phase ratio of n-hexane to ethyl acetate to methanol to normal propyl alcohol is (58-62): (42-38): 2: 1, the ultraviolet detection wavelength is 265 + / -2nm, the flow rate is 1.1-1.3 ml / min, and the column temperature is 25-35 DEG C. On the basis of calcitriol active ingredients, the invention develops a high performance liquid chromatography analysis method which is simple and efficient to operate, strong in specificity, high in recovery rate and low in detection limit.

Description

technical field [0001] The invention belongs to the technical field of chemical preparations, and in particular relates to a detection method for cleaning verification of calcitriol soft capsule production equipment. Background technique [0002] After the preparation production process is completed, all used equipment will produce relevant material residues. At this time, the relevant equipment needs to be cleaned. If the cleaning method is unreasonable or the cleaning effect cannot be reflected, it may affect subsequent batch production or cause cross-contamination. [0003] At present, TOC (total organic carbon method) is the most widely used analysis method for the cleaning verification of pharmaceutical production equipment. The method has good linearity, high recovery rate and precision, especially for complex organic components, and has good detection effect. However, due to the low content of active ingredients in calcitriol soft capsules (0.5 μg / capsule) and the in...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 朱乾坤沙薇马宗普朱盼盼
Owner HENAN TAIFENG BIOTECH CO LTD
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com