IND SWIFT LABORTARIES LTD.

DCRUST, MURTHAL

Overview

Company Profile Major Reaction and Reagents Capabilities Company Products Different Units of the company

Company Profile Ind-Swift Laboratories Ltd. (ISLL) is a USD ~ 200 million, fast growing active

pharmaceutical ingredient (API) and contract research and manufacturing services (CRAMS) company, based in Chandigarh, North India. 

Established in 1995 Ind-Swift has fast evolved towards a business model that is focused on deep-rooted domestic presence and leveraged on high-value mature regulated markets along with considerable growth in emerging markets:

Ind-Swift Laboratories Ltd. (Manufacturer of APIs) Ind-Swift Laboratories Inc. (US Subsidiary) Ind Swift Menthol With manufacturing sites at 6 different locations across India and an

independent State-of-the-Art R&D Centre, the Group has embarked upon a journey to establish itself as reliable partner in the Global Pharmaceutical Industry. In house capabilities for Development of APIs, Finished Dosage forms, Non-Infringing Process & World Class facilities for Contract Manufacturing are the inherent strengths.

ISLL–CRAMS offers world class services across early phase drug development, process R&D, contract manufacturing to analytical and regulatory services.

Major Reaction and Reagents Capabilities Grignard Reaction Friedel-crafts Acylation Hydrogenation Halogenation Witting Reaction Stetter Reaction Arbuzov Reaction

Company Products

Few of the major products that are produced in here are :- Clarithromycin Roxithromycin Azithromycin Ezetimbe Clopidogrel Hydrogen Sulphate Fexofenadine HCl Nateglinide

Different Sections

Research & Development CentreQuality Control Unit

High Performance Liquid Chromatography Gas ChromatographyMicrobiology

Production Unit

Research & Development

R&D includes basically the fulfillment of the demands of the masses by thoroughly researching and developing new ways or products as per their requirements. Few of the basic products that are produced here are :-

Clarithromycin Roxithromycin Azithromycin Ezetimbe Clopidogrel Hydrogen Sulphate Fexofenadine HCl Nateglinide

Quality Control & Quality Assurance

Quality control (QC) is a procedure or set of procedures intended to ensure that a manufactured product or performed service adheres to a defined set of quality criteria or meets the requirements of the masses. QC is similar to, but not identical with quality assurance (QA). QA is defined as a procedure or set of procedures intended to ensure that a product or service under development (before work is complete, as opposed to afterwards) meets specified requirements. QA is sometimes expressed together with QC as a single expression, quality assurance and control (QA/QC).

Quality Control Unit

Quality Control Unit consists :HPLC lab (High performance liquid chromatography lab) GC lab (Gas chromatography lab)Microbiology lab

High Performance Liquid Chromatography High-performance liquid chromatography (formerly referred to as high-

pressure liquid chromatography), HPLC, is a chromatographic technique used to separate the components in a mixture, to identify each component, and to quantify each component.

In general, the method involves a liquid sample being passed over a solid adsorbent material packed into a column using a flow of liquid solvent. Each analyte in the sample interacts slightly differently with the adsorbent material, thus retarding the flow of the analytes. If the interaction is weak, the analytes flow off the column in a short amount of time, and if the interaction is strong, then the elution time is long. 

 HPLC has been used in medical (e.g. detecting vitamin D levels in blood serum), legal (e.g. detecting performance enhancement drugs in urine), research (e.g. separating the components of a complex biological sample, or of similar synthetic chemicals from each other), and manufacturing (e.g. during the production process of pharmaceutical and biological products).

High Performance Liquid Chromatography Lab The lab consists of three basic instruments which are :

Reservoir Column Detector

The reservoir brings the sample mixture into the mobile phase stream which carries it into the column. The pumps deliver the desired flow and composition of the mobile phase through the column. The detector generates a signal proportional to the amount of sample component emerging from the column, hence allowing for quantitative analysis of the sample components.

High Performance Liquid Chromatography Lab

Schematic Diagram for HPLC

Reservoir

The reservoir in HPLC is generally preferred mobile phase reservoir . Mobile phase reservoir will carry the mobile phase solution and through the

pump it will be pumped into the column. This movement is according to the gravitational force. The mobile phase reservoir is a solvent with different polarities such as water, methanol, and acetonitrile.

These solvents should be highly pure. For an example, water should be used as de-ionized water. Hygienic conditions are facilitated with the use of 0.45 µm filter. The solvent is filtered through this filter mesh to remove all particulate matter. This is termed as Millipore filtering. Degas is done to minimize errors which occur when compounds interact with several gases. If degas or the removal of all the gases, is not done correctly then it may spoil the column.

Column

Column is considered as the “Heart “ of the whole process . The separation of the compound mixture takes place in this column or HPLC tube.

The HPLC tube is made up of stainless steel. The stationary phase is packed in the column and it is usually a solid adsorbent. In some instances the solid adsorbent is packed with a thin layer of water. Thus the physical principle or the mode of separation in HPLC is partition.As in other chromatographic techniques in HPLC the mobile phase with the test sample is gone through the stationary phase. And the compounds in the test sample are separated in here. Mobile phase serves only as a carrier of the test sample. According to the solubility differences (in other words polarity differences) the mixed compounds are separated

Many different types of columns are available, filled with sorbents varying in particle size, and in the nature of their surface ("surface chemistry"). The use of smaller particle size packing materials requires the use of higher operational pressure ("backpressure") and typically improves chromatographic resolution (i.e. the degree of separation between consecutive analytes emerging from the column).

Column

Detector

Detector records the relative concentrations of different components of the test sample with respect to their retention time. Retention time is the time taken by the compound to elute from the column. Retention time is calculated from the time of injection until the compound is eluted. Detection is based on several different physical principals. 

Those are UV absorption, fluorescence, radioactivity, IR absorption and electrochemical gradient. Depending on the characteristics of the mixture the physical principals will be different.

The one we use here is Dual wavelength absorbance detector or PDA Detector .

The Process

The microprocessor shows the chromatograms which consists of small peaks and major peaks hence defining the amount of the required substance to be separated.

The pressure required is 5000 psi in case of HPLC and 15000 psi for UPLC which is at times preferred for the separation in industry.

This way the whole process takes place in 24 – 48 hrs depending upon the product to be manufactured.

For Clarithromycin it takes 28 hrs of separation process.

The Process

The process begins with the mixing of various chemical required to prepare the requirement as discussed in STP (Standard Testing Procedure) and is then further placed in sampler so as to begin the process of chromatography which proceeds towards column.

The column is filled with tiny silica particles, and the solvent is non-polar - hexane, for example. A typical column has an internal diameter of 4.6 mm (and may be less than that), and a length of 150 to 250 mm.

Polar compounds in the mixture being passed through the column will stick longer to the polar silica than non-polar compounds will. The non-polar ones will therefore pass more quickly through the column.

Then after moving from column it goes to detector where the required things are detected and that is shown on a digital microprocessor and user software controls the HPLC instrument and provide data analysis

HPLC Chromatogram

Gas Chromatography Lab

Gas chromatography is used in analytical chemistry for separating and analyzing compounds that can be vaporized without decomposition.  the mobile phase  is a carrier gas, usually an inert gas such as He or an unreactive gas such as N2 The stationary phase is a microscopic layer of liquid or polymer on an inert solid support, inside a piece of glass or metal tubing called a column .

Gas Chromatography Lab

The Process

A known volume of gaseous or liquid analyte is injected into the "entrance" (head) of the column, usually using a microsyringe (or, solid phase microextraction fibers, or a gas source switching system). As the carrier gas sweeps the analyte molecules through the column, this motion is inhibited by the adsorption of the analyte molecules either onto the column walls or onto packing materials in the column. The rate at which the molecules progress along the column depends on the strength of adsorption, which in turn depends on the type of molecule and on the stationary phase materials. Since each type of molecule has a different rate of progression, the various components of the analyte mixture are separated as they progress along the column and reach the end of the column at different times (retention time). A detector is used to monitor the outlet stream from the column; thus, the time at which each component reaches the outlet and the amount of that component can be determined.

Gas Chromatogram