Development and Certification of Calcium Chloride Casein Reference Standard

In accordance with the requirements of the State Pharmacopoeia of the Russian Federation, 14th edition, Clostridium novyi 198 test strain is used to determine growth promoting properties of thioglycollate medium when testing sterility of immunobiological medicinal products. The preservation of C. novyi 198 as spores requires a special liquid medium containing insoluble calcium chloride casein (CChC). At present, there is no reference standard available on the Russian market for the quality control of CChC used as a component of the media for preservation of C. novyi 198.The aim of the study was to develop and certify the first batch of calcium chloride casein industry reference standard (IRS) for the quality control of CChC batches and liquid media containing CChC which is used to preserve C. novyi 198 as spores.Materials and methods: thermally denatured CChC which was chemically synthesized from industrial CChC was used as candidate material. The quality control was performed using the test procedures described in procedural guidelines MUK 4.2.2316-08. C. novyi 198 spores were obtained as described in the «Sterility testing» section of MUK 4.2.2316-08 (preparation, inoculation and incubation in the medium containing calcium chloride casein IRS).Results: a list of quality parameters was developed for calcium chloride casein IRS: «Spore formation» (certifiable parameter), «Appearance», «Loss on drying», «Clarity of medium». The first batch of the candidate calcium chloride casein IRS was certified. The value of the «Spore formation» certifiable parameter was found to be (32.6 ± 7.3) %, the IRS shelf life was 5 years when stored in a dry place protected from light at a temperature of 15 to 25 °C. A documentation package for the IRS 4228-444-2018 was prepared and approved. The liquid medium containing CChC reference material (0.3 g/10 mL) allows for preservation of the biological properties of the C. novyi 198 working culture for at least 12 months.Conclusions: the certification results demonstrate that the calcium chloride casein IRS meets the applicable requirements and can be used as reference material to control the quality of new CChC batches and to assess the suitability of liquid medium containing CChC for preservation purposes. The use of the calcium chloride casein IRS makes it possible to standardise and greatly simplify the procedure for preserving the stability of C. novyi 198, to increase the efficiency and reliability of immunobiologicals quality control in terms of Sterility, and to reduce costs when using a freeze-dried strain.

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BIOASSAY CHARACTERISTICS OF INDIVIDUAL URINARY GONADOTROPHIN EXTRACTS

Acta Endocrinologica ◽

10.1530/acta.0.0420214 ◽

1963 ◽

Vol 42 (2) ◽

pp. 214-224

Author(s):

Raymond C. Mellinger ◽

Jalileh A. Mansour ◽

Richmond W. Smith

Keyword(s):

Reference Material ◽

Young Women ◽

Reference Standard ◽

General Acceptance ◽

Modifying Factors ◽

Large Numbers ◽

The World ◽

Quantitative Bioassay ◽

Different Parts ◽

Age And Sex

ABSTRACT A reference standard is widely sought for use in the quantitative bioassay of pituitary gonadotrophin recovered from urine. The biologic similarity of pooled urinary extracts obtained from large numbers of subjects, utilizing groups of different age and sex, preparing and assaying the materials by varying techniques in different parts of the world, has lead to a general acceptance of such preparations as international gonadotrophin reference standards. In the present study, however, the extract of pooled urine from a small number of young women is shown to produce a significantly different bioassay response from that of the reference materials. Gonadotrophins of individual subjects likewise varied from the multiple subject standards in many instances. The cause of these differences is thought to be due to the modifying influence of non-hormonal substances extracted from urine with the gonadotrophin and not necessarily to variations in the gonadotrophins themselves. Such modifying factors might have similar effects in a comparative assay of pooled extracts contributed by many subjects, but produce significant variations when material from individual subjects is compared. It is concluded that the expression of potency of a gonadotrophic extract in terms of pooled reference material to which it is not essentially similar may diminish rather than enhance the validity of the assay.

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Synthesis, Analytical Characterization and Spectroscopic Investigation of Chloramphenicol Impurity A for the Quality Control of Chloramphenicol and its Formulation as Per International Compendium

Current Organic Synthesis ◽

10.2174/1570179417666200410170237 ◽

2020 ◽

Vol 17 (5) ◽

pp. 382-388

Author(s):

Aparna Wadhwa ◽

Faraat Ali ◽

Sana Parveen ◽

Robin Kumar ◽

Gyanendra N. Singh

Keyword(s):

Quality Control ◽

Synthesis Method ◽

Analytical Techniques ◽

International Markets ◽

Therapeutic Effects ◽

Reference Standard ◽

Working Standard ◽

Prior Art ◽

New Synthesis ◽

Synthetic Procedure

Objective: The main aim of the present work is to synthesize chloramphenicol impurity A (CLRMIMP- A) in the purest form and its subsequent characterization by using a panel of sophisticated analytical techniques (LC-MS, DSC, TGA, NMR, FTIR, HPLC, and CHNS) to provide as a reference standard mentioned in most of the international compendiums, including IP, BP, USP, and EP. The present synthetic procedure has not been disclosed anywhere in the prior art. Methods: A simple, cheaper, and new synthesis method was described for the preparation of CLRM-IMP-A. It was synthesized and characterized by FTIR, DSC, TGA, NMR (1H and 13C), LC-MS, CHNS, and HPLC. Results: CLRM-IMP-A present in drugs and dosage form can alter the therapeutic effects and adverse reaction of a drug considerably, it is mandatory to have a precise method for the estimation of impurities to safeguard the public health. Under these circumstances, the presence of CLRM-IMP-A in chloramphenicol (CLRM) requires strict quality control to satisfy the specified regulatory limit. The synthetic impurity obtained was in the pure form to provide a certified reference standard or working standard to stakeholders with defined potency. Conclusion: The present research describes a novel technique for the synthesis of pharmacopoeial impurity, which can help in checking/controlling the quality of the CLRM in the international markets.

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Development and Certification of Formononetin Reference Material for Quality Control of Functional Foods and Botanical Supplements

Current Analytical Chemistry ◽

10.2174/1573411014666180411152309 ◽

2019 ◽

Vol 15 (5) ◽

pp. 553-559

Author(s):

Ningbo Gong ◽

Baoxi Zhang ◽

Kun Hu ◽

Zhaolin Gao ◽

Guanhua Du ◽

...

Keyword(s):

Quality Control ◽

Reference Material ◽

Functional Foods ◽

Certified Reference Materials ◽

Coulometric Titration ◽

Pharmaceutical Formulations ◽

Uncertainty Estimation ◽

Expanded Uncertainty ◽

Scanning Calorimetry ◽

Botanical Supplements

Background: Formononetin is a common soy isoflavonoid that can be found abundantly in many natural plants. Previous studies have shown that formononetin possesses a variety of activities which can be applied for various medicinal purposes. Certified Reference Materials (CRMs) play a fundamental role in the food, traditional medicine and dietary supplement fields, and can be used for method validation, uncertainty estimation, as well as quality control. Methods: The purity of formononetin was determined by Differential Scanning Calorimetry (DSC), Coulometric Titration (CT) and Mass Balance (MB) methods. Results: This paper reports the sample preparation methodology, homogeneity and stability studies, value assignment, and uncertainty estimation of a new certified reference material of formononetin. DSC, CT and MB methods proved to be sufficiently reliable and accurate for the certification purpose. The purity of the formononetin CRM was therefore found to be 99.40% ± 0.24 % (k = 2) based on the combined value assignments and the expanded uncertainty. Conclusion: This CRM will be a reliable standard for the validation of the analytical methods and for quality assurance/quality control of formononetin and formononetin-related traditional herbs, food products, dietary supplements and pharmaceutical formulations.

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Chromium powder as a reference material for the quality control of particle-size measurement by laser diffraction

Powder Technology ◽

10.1016/j.powtec.2005.05.041 ◽

2005 ◽

Vol 155 (1) ◽

pp. 85-91 ◽

Cited By ~ 2

Author(s):

N. Etxebarria ◽

G. Arana ◽

R. Antolín ◽

E. Diez ◽

G. Borge ◽

...

Keyword(s):

Particle Size ◽

Quality Control ◽

Reference Material ◽

Laser Diffraction ◽

Size Measurement ◽

Chromium Powder ◽

Particle Size Measurement

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Biological and Mechanical Properties of Platelet-Rich Fibrin Membranes after Thermal Manipulation and Preparation in a Single-Syringe Closed System

International Journal of Molecular Sciences ◽

10.3390/ijms19113433 ◽

2018 ◽

Vol 19 (11) ◽

pp. 3433 ◽

Cited By ~ 11

Author(s):

Dorottya Kardos ◽

István Hornyák ◽

Melinda Simon ◽

Adél Hinsenkamp ◽

Bence Marschall ◽

...

Keyword(s):

Mechanical Properties ◽

Tensile Strength ◽

Cell Adhesion ◽

Closed System ◽

Three Dimensional ◽

Glass Tube ◽

Biological Properties ◽

Platelet Rich Fibrin ◽

Handling Characteristics ◽

Freeze Dried

Platelet-rich fibrin (PRF) membrane is a three-dimensional biodegradable biopolymer, which consists of platelet derived growth factors enhancing cell adhesion and proliferation. It is widely used in soft and hard tissue regeneration, however, there are unresolved problems with its clinical application. Its preparation needs open handling of the membranes, it degrades easily, and it has a low tensile strength which does not hold a suture blocking wider clinical applications of PRF. Our aim was to produce a sterile, suturable, reproducible PRF membrane suitable for surgical intervention. We compared the biological and mechanical properties of PRF membranes created by the classical glass-tube and those that were created in a single-syringe closed system (hypACT Inject), which allowed aseptic preparation. HypACT Inject device produces a PRF membrane with better handling characteristics without compromising biological properties. Freeze-thawing resulted in significantly higher tensile strength and higher cell adhesion at a lower degradation rate of the membranes. Mesenchymal stem cells seeded onto PRF membranes readily proliferated on the surface of fresh, but even better on freeze/thawed or freeze-dried membranes. These data show that PRF membranes can be made sterile, more uniform and significantly stronger which makes it possible to use them as suturable surgical membranes.

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A Preparation Method of β-Carotene Reference Standard from β-Carotene Food Additive Based on High Speed Countercurrent Chromatography (HSCCC)

Key Engineering Materials ◽

10.4028/www.scientific.net/kem.871.293 ◽

2021 ◽

Vol 871 ◽

pp. 293-299

Author(s):

Lan Tao ◽

Zhi Ming Wang ◽

Shu Huan Lu ◽

Liu Liu Xu ◽

Mu Zi Li ◽

...

Keyword(s):

Quality Control ◽

Sample Preparation ◽

High Speed ◽

Preparation Method ◽

Food Additive ◽

Countercurrent Chromatography ◽

Reference Standard ◽

Health Food ◽

Simple Method ◽

Β Carotene

The paper provided a simple method for preparing the β-carotene reference standard from a β-carotene food additive (96%) based on high speed countercurrent chromatography (HSCCC). The obtained material was qualitatively detected by IR, NMR, MS, the results showed the material was purified β-carotene, the purity of obtained β-carotene reference standard can be as high as 99%. The prepared reference standard can be used for quality control of related health food. The provided method is simple, universal, cheap, and the sample preparation can be enlarged to g grade.

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Calcium chloride dihydrate affects the biological properties of white mineral trioxide aggregate on dental pulp stem cells: An in vitro study

Saudi Endodontic Journal ◽

10.4103/sej.sej_40_17 ◽

2018 ◽

Vol 8 (1) ◽

pp. 25 ◽

Cited By ~ 2

Author(s):

Norhayati Luddin ◽

HanyMohamed Aly Ahmed ◽

ThirumuluPonnuraj Kannan ◽

KhairaniIdah Mokhtar ◽

Azlina Ahmad

Keyword(s):

Stem Cells ◽

Calcium Chloride ◽

Dental Pulp ◽

Mineral Trioxide Aggregate ◽

In Vitro Study ◽

Biological Properties ◽

Chloride Dihydrate ◽

Calcium Chloride Dihydrate ◽

White Mineral

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Authentication of the Bilberry Extracts by an HPLC Fingerprint Method Combining Reference Standard Extracts

Molecules ◽

10.3390/molecules25112514 ◽

2020 ◽

Vol 25 (11) ◽

pp. 2514

Author(s):

Bingbing Liu ◽

Tiantian Hu ◽

Weidong Yan

Keyword(s):

Quality Control ◽

High Performance Liquid Chromatography ◽

Liquid Chromatography ◽

High Performance ◽

Reference Standard ◽

Black Rice ◽

Hplc Fingerprint ◽

Berry Extracts ◽

Bilberry Extract

A simple and fast high-performance liquid chromatography (HPLC) fingerprint method combining reference standard extract for the identification of bilberry extract was developed and validated. Six batches of bilberry extract collected from different manufactures were used to establish the HPLC fingerprint. Other berry extracts—such as blueberry extracts, mulberry extracts, cranberry extracts, and black rice extracts—were also analyzed for their HPLC chromatograms. The fingerprints of five batches of bilberry extract showed high similarities, while one batch was distinguished from others. Additionally, the content of anthocyanin Cyanidin-3-O-glucoside (Cy-3-glc) in each berry extract was analyzed and compared. The results indicate that this HPLC fingerprint method, combining reference standard extracts, could be used for the authentication and quality control of bilberry extracts.

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An effective method for quality control of the thermocouple

MATEC Web of Conferences ◽

10.1051/matecconf/201817301029 ◽

2018 ◽

Vol 173 ◽

pp. 01029

Author(s):

Tingting Wang ◽

Yajun Yan ◽

Yiwen Yuan ◽

Zhuang Ma ◽

Ailiang Zhang ◽

...

Keyword(s):

Energy Efficiency ◽

Quality Control ◽

Convenient Method ◽

Reference Standard ◽

Standard Temperature ◽

New Energy ◽

Energy Products ◽

Qualification Rate

As a basic testing element, the thermocouples are widely used in the safety and energy efficiency testing of the electronic and electrical products, new energy products and so on. The accuracy of all thermocouples can't be assured for they are mostly calibrated by sampling. In view of this situation, an efficient and convenient method for the intermediate check of the thermocouple is proposed in this paper. Taking 0 degree and 100 degree which can be easily obtained in the nature as the reference standard temperature, the deviation of the testing thermocouples and the reference standard temperature can be determined and the qualification rate of the thermocouples can be obtained. This method can promote the quality control of the laboratory.

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