Seth G.L. Bihani S.D. College of Technical Education

H-NMR SPECTROSCOPY: AN INTRODUCTION

About Authors:
Arshad Hala*, Prof. Rajesh Dholpuria, Nilesh sovasia
Seth G. L. Bihani S. D. College Of Technical Education,
Institute Of Pharmaceutical Sciences & Drug Research,
Gaganpath, Sri Ganganagar, Rajasthan 335001
*Arshad_hala@yahoo.com

ABSTRACT:
Over the past fifty years nuclear magnetic resonance spectroscopy, commonly referred to as NMR, has become the preeminent technique for determining the structure of organic compounds. Nuclear Magnetic Resonance (NMR) spectroscopy is an analytical chemistry technique used in quality control and research for determining the content and purity of a sample as well as its molecular structure. For example, NMR can quantitatively analyze mixtures containing known compounds. For unknown compounds, NMR can either be used to match against spectral libraries or to infer the basic structure directly. Once the basic structure is known, NMR can be used to determine molecular conformation in solution as well as studying physical properties at the molecular level such as conformational exchange, phase changes, solubility, and diffusion.Of all the spectroscopic methods, it is the only one for which a complete analysis and interpretation of the entire spectrum is normally expected. Although larger amounts of sample are needed than for mass spectroscopy, NMR is non-destructive, and with modern instruments good data may be obtained from samples weighing less than a milligram. To be successful in using NMR as an analytical tool, it is necessary to understand the physical principles on which the methods are based.

IMPURITIES AN OVERVIEW

About Authors:
Lila dhar*, Prof. Sanjeev Thacker, Jatin Patel
Seth G. L. Bihani S.D. College Of Technical Education, Institute Of Pharmaceutical Sciences & Drug Research,
Gaganpath, Sri Ganganagar, Rajasthan 335001
*ldbudania@gmail.com

ABSTRACT
Impurities is defined as an entity of drug substances or drug product that is not chemical entity defined as drug substances an excipients or other additives to drug product. In pharmaceutical world, an impurity is generally considered as an other organic material beside the other drug substances that is arises out of the synthesis most of the time, inorganic contaminants are not considered as an impurity unless they are toxic, such as heavy metal or arsenic. There are numerios source of impurities and many different common terms are use for impurities such as by product, intermediate, transformation on product, related product, interaction product and degradation products.

Thermogravimetry

About Authors:
Jatin  Patel*
Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA
*Patelj313@yahoo.com

ABSTRACT:
Thermogravimetry
is a branch of physical chemistry, materials research, and thermal analysis. It is based on continuous recording of mass changes of a sample of material, as a function of a combination of temperature with time, and additionally of pressure and gas composition.

It includes different types of Thermogravimetric analysis. In this article types, Instrumentation, Procedure, Application are priscribed.

NEW DRUG APPROVAL PROCEDURE IN INDIA

About Authors:
Jatin  Patel*, Krunal Parikh, Dhiren Shah
Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA
*Patelj313@yahoo.com

ABSTRACT:
A regulatory process, by which a person/organization/sponsor/innovator gets authorization to launch a drug in the market, is known as drug approval process. In general, a drug approval process comprises of various stages: application to conduct clinical trials, conducting clinical trials, application to marketing authorization of drug and post-marketing studies. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs.
This article includes new drug approval process in different countries include India, Australia, European union, China etc.
New drug approval process in different countries are described in logarithmic representation.

PHYSICAL STABILITY TESTING OF DRUGS AND DRUG PRODUCTS

About Authors:
L.D.Budania
Seth G. L. Bihani S. D. College Of Technical Education,
Institute Of Pharmaceutical Sciences & Drug Research, Gaganpath,
Sri Ganganagar, Rajasthan 335001
*ldbudania@gmail.com

ABSTRACT:
Stability is an essential quality attribute for drug products. If there is any functionally relevant quality attribute of a drug product that changes with time, this evaluation checked by pharmaceutical scientist and regulators who quantify drug product stability and shelf life. The rate at which drug products degrade varies dramatically. E.g. radiopharmaceutical products. Since the evaluation of the stability of drug is highly specialized and esoteric nature. Drug stability concerns about drug product safety, efficacy, and quality, found it to appropriate. Stability studies are done through the regulatory agencies such as FDA and HPB (health protection branch).

MANUFACTURING DOCUMENTATION IN PHARMACEUTICAL INDUSTRY- DEVELOPMENT AND IMPLEMENTATION

About Authors:
Krunal Parikh1*, Mr. Maheshkumar Kataria2, Jatin Patel1
2Assistant professor, Department of pharmaceutics,
1Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA
*Krunal_2922@yahoo.in

ABSTRACT
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized. It consequently strengthens the quality, and its consistency, of all goods and services, as those responsible for the specific operations have clear, unambiguous instructions to follow including active drug substances, is legally mandatory.

ESSENTIAL ELEMENTS OF PATENT

About Authors:
Jatin  Patel1*, Prof. Rajesh Kumar Dholpuria2, Dhiren Shah1
2(Professor, Head of Department of pharmacognosy),
1Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA
*Patelj313@yahoo.in

ABSTRACT
Patent Right varies from country to country. In India the law which govern patent right is "Indian Patent Act 1970". Indian Patent Act, 1970 grants exclusive right to the inventor for his invention for limited period of time. Generally 20 years time has been granted to the patent holder but in case of inventions relating to manufacturing of food or drugs or medicine it is for seven years from the date of patent. There is certain legal procedure which needs to be followed in order to register. There are several attorney helping inventor in patent registration by providing them best well informed knowledge. In India patent registration can be filed individually or jointly. In case of deceased inventor this can be done his legal representative on behalf of him. All the required documents need to be filed along with the application form. Only after verification registration certificate is provided to the applicant.

QUALITY PHILOSOPHY FOR PHARMACEUTICAL CONTAINERS AND CLOSURES

About Authors:
*Tarun Patel, Prof. Dr. Vipin Kukkar, Arshad hala, Dhiren Shah
Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA
*tarunpatel35@gmail.com

ABSTRACTS:
In pharma industry containers and closures play important role for improving quality of pharma products in market. For improving quality of containers and closures there are different types of raw materials are used like glass, plastic, rubber, metal etc. Out of that all raw materials in manufacturing of containers and closures widely use is plastic because of its less interaction with product as compare to other materials. In this review articles we discuss about quality of containers and closures.

PACKAGING AND LABELLING CONTROL ACCORDING TO GLOBAL GMP

About Authors:
*Tarun Patel, Prof. Dr. Vipin Kukkar, Krunal Parik
Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA
*tarunpatel35@gmail.com

ABSTRACT:
In pharma industry Packaging and Labelling plays very important role for improvements of attraction to human beings. So by improving our packaging and labeling style we can easily improve our product market value. Green packaging is also an alternative to make packaging more environmental friendly which would not affect the nature in any way. The most desirable solution is “use less, discard less, save more, reuse more”In this review article we discuss briefly about the requirement of packaging and labeling control of product according to different GMPs.

EVALUATION OF CRUDE DRUGS, MONO OR POLYHERBAL FORMULATION

About Authors:
Dhiren Shah*1, Jatin Patel, Krunal Parikh
m.pharmacy
Seth G.L. Bihani S.D. College of Technical Education, R.U.H.S.
Sri Ganganagar, Rajasthan, INDIA
*dhiren.pharmacist@gmail.com

Abstract :
Involved Evaluation and Standardization techniques for crude drugs, mono or Polyherbal Frormulation. They involved the macroscopic techniques, microscopic techniques, physical evaluation and biological evaluation. They also involved the Quantitative analysis of Organophosphorus insecticides, Organochlorine and pyrethroid insecticides, microbial content determination.

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