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Polarimeter - introduction, Defination, apparatus and precautions for use in details

POLARIMETRY

Introduction
The electric fields associated with the beam of monochromatic light, vibrate in all directions perpendicular to the directions of propagation of light. Certain crystalline materials have different refractive indices for light, whose field vibrates parallel or perpendicular to the principal plane of the crystal. As a result, a Nicol prism constructed of this material transmits only light whose electric field oscillates in one plane. Optical activity concerns with the interaction of such plane polarised light with certain materials, particularly solutions of some organic compounds.

When a plane polarised light passes through a medium, it is retarded to an extent indicated by the refractive index of the medium. When the later is optically inactive, both circularly polarised components are retarded to the same extent and the beam emerges from the medium, polarised in the same plane as the incident beam. If the medium is optically active, the components are retarded to different extents and the beam emerges from the medium still plane polarised; but with the plane of polarisation inclined at an angle to the plane of polarisation of the incident beam. If the plane of polarisation is rotated clockwise, the substance is termed 'dextrorotatory', while if the plane of polarisation is rotated anticlockwise, the substance is termed 'laevorotatory'. Dextrorotation is designated (+) and laevorotation is designated (-).

Definitions

a) Optical Rotation : Optical rotation, unless otherwise specified, is measured at the wavelength of the 'D' line of Sodium (wavelength = 589.3 nm), at 25°C, on a layer 1 dm thick. It is expressed in degrees.

b) The specific optical rotation : The specific optical rotation of a liquid substance is the angle of rotation of the plane of polarisation at the wavelength of the 'D' line of Sodium, measured at 25°C unless otherwise specified, calculated with reference to a 1 dm thick layer of liquid and divided by the specific gravity of the liquid at 25°C.

The specific optical rotation of a solid substance is the angle of rotation of the plane of polarisation at the wavelength of the 'D' line of Sodium, measured at 25°C unless otherwise specified, calculated with reference to a 1 dm thick layer of a solution containing one gm of the substance per ml. The specific optical rotation of a solid is always expressed with reference to a given solvent and concentration.

Apparatus
The apparatus for measurement of rotation of a compound is known as the, Polarimeter.

It Consist of following parts

a) Light source -The source of light is usually Sodium vapour lamp, which emits monochromatic light.

b) Polariser - The polariser consists of a fixed Nicol prism at one end to convert ordinary light into plane polarised light.

c) Sample compartment -In this compartment the sample is placed in 1 dm or 2 dm tube. In the case of solids, a suitable solution is made, through which the plane polarised light is passed.

d) Analyser - The analyser consists of a movable Nicol prism, with a scale marked off in degrees. This is placed at the other end of the polarimeter.



e) Eye piece -The eye piece is placed at the analyser end.

Calibration -The polarimeter is calibrated using a solution of previously dried Sucrose and measuring the optical rotation in a 2 dm tube at 25°C for concentrations ranging from 10% w/v to 50% w/v.

The angle of rotation is as given in following table :

Concentration.   Angle of rotation

 g /100ml.            at 25°C

10.0       -             13.33°

20.0        -            26.61°

30.0.       -            39.86°

40.0        -            53.06°

50.0.       -            66.23°


Alternatively a quartz control plate with known optical activity can be used for calibration.

Precautions
The accuracy and precision of optical rotation measurements can be increased, if following precautions are taken

a) The instrument must be in a good condition. The optical elements must be very clean and in exact alignment.

b) Specific attention should be paid to the temperature control of the solution and the polarimeter.

c) Five consecutive readings are taken and the mean of these five readings is used for calculations to improve precision.

d) Polarimeter tube must be filled in such a way as to avoid air bubbles.

e) For tube with removable end plates fitted with gaskets and caps, the end plates must be tightened to ensure a leak proof seal between the end plate and the body of the tube.

f) For substances with low rotatory power, the end plates should be loosened and tightened again after each reading.

g) Spillage of the sample must be avoided.

h) The tube having the sample must be thoroughly cleaned. Liquid and solution of solids must be clear. 

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Method of starch paste preparation for granulation tablet manufacturing

Material

1.  Starch 
2. Preservative  - sodium methyl paraben, sodium propyl paraben etc.
3. Binder - PVPK 30/40/60 , sugar,  gelatin etc.
4. Sufactant - sodium Lauryl sulphate etc.

 5. Base - Purified Water

Procedure
      1. Take purified water in paste kettle and add surfactant and preservatives to it now
     2. Heat the purified water to 100°C till boil
     3. Dissolve starch in purified water in separate vessel and stirr till traslucent mass obtained
    4. Add this translucent mass to hot purified water in paste kettle and stirr till it become slightly yellowish

LIST OF SCHEDULES AS PER DRUGS AND COSMETIC ACT 1948

Indian pharmaceutical GMP guidelines are given in Drugs & Cosmetics Act 1940. Rules are given for pharmaceuticals and schedules are there to comply those rules.

MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health) updates this time to time. Pharmaceutical industries in India those are manufacturing the drug products for domestic market have to follow the Drugs & Cosmetics Act.

It contains 168 rules from 1 to 168 and 25 Schedules from Schedule A to Schedule Y.

Different type of forms are also given for different type of approvals from drug authorities.

Following are the schedules:

Schedule A: Forms and applications

Schedule B: Fees for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories

Schedule C: Biological and Special Products

Schedule C(1): Other Special Products

Schedule D: Class of Drugs: Extent and conditions of exemption

Schedule D(I): Information and undertaking required to be submitted by the manufacturer of his authorized agent with the application form for a Registration Certificate. The format shall be properly filled in for each application in Form 40. The detailed information, secret in nature, may be furnished on a computer floppy.

Schedule D(II): Information required to be submitted by the manufacturer or his authorized agent with the application form for the registration of a bulk drug/formulation/special product for its import into India. The format shall be properly filled in and the detailed information, secret in nature, may be furnished on a computer floppy.

Schedule E: Omitted

Schedule E(1): List of Poisonous Substances under the Ayurvedic (including Siddha) and Unani Systems of Medicine

Schedule F: Part I to Part XII-A – Omitted

Part XII-B: Requirements for the functioning and operation of a Blood Bank and / or for preparation of Blood Components
(I) Blood Banks / Blood Components
(II) Blood Donation Camps
(III) Processing of Blood Components from whole blood by a Blood Bank
Part XII-C:

(I)  Requirements for manufacture of Blood Products

(II)  Requirements for manufacture of Blood products from bulk finished products

Part XIII: General

Schedule F(I):

Part I: Vaccines

(A) Provisions applicable to the production of Bacterial Vaccines

(B) Provisions applicable to the production of Viral Vaccines

Part II: Antisera

           Provisions applicable to the production of all sera from living animals

Part II: Diagnostic Antigens

           Provisions applicable to the manufacture and standardization of Diagnostic Agents (Bacterial Origin)

Part IV: General

Schedule F(II): Standards for Surgical Dressings

Schedule F(III): Standards for umbilical Tapes

Schedule FF: Standards for Ophthalmic Preparations
Schedule G:
Schedule H: Prescription Drugs

Schedule I: Omitted

Schedule J: Disease and ailment (by whatever name described ) which a drug not purport to prevent or cure.

Schedule K: Class of drug: Extent and conditions of exemption

Schedule L1: Good Laboratory Practice

Schedule M: Good manufacturing practices and requirements of premises,  plant and equipment for Pharmaceutical product.

Part I: Good manufacturing practices for premises and materials.

Part I-A: Specific requirements for manufacture of sterile products, parenteral preparation (small volume injectables and large volume parenterals ) and sterile ophthalmic preparation  

Part I-B: Specific requirement for manufacturing of oral solid dosage forms (Tablet and Capsules).

Part I-C: Specific requirement for manufacture of oral liquids (Syrups, elixirs, emulsions and suspensions).

Part I-D: Specific requirements for manufacture of topical products i.e. external preparation (creams, ointments, pastes, emulsions, lotions, solutions, dusting powders and identical products) 

Part I-E: Specific requirements for manufacture of metered-dose-inhalers (MDI)

Part I-F: Specific requirements of premises, plant and materials for manufacture of active pharmaceutical ingredients ( Bulk Drugs ).

Part II: Requirements of plant and equipment.

Schedule M-I: 1. Requirements of factory premises for manufacture of homoeopathic preparations.

2. Requirements of plants and equipments.

Schedule M-II: Requirements of factory premises for manufacture of cosmetic.

Schedule M-III: Requirements of factory premises for manufacture of medical devices.

Part I-B: Specific requirement for manufacturing of oral solid dosage forms  (Tablet and Capsules).

Part I-C: Specific requirement for manufacture of oral liquids ( Syrup, elixirs, emulsions and suspensions).

Part I-D: Specific requirements for manufacture of topical products i.e. external preparation ( creams, ointments, pastes, emulsions, lotions, solutions, dusting powders and identical products )  

Part I-E: Specific requirements for manufacture of metered-dose-inhalers (MDI)

Part I-F: Specific requirements of premises, plant and materials for manufacture of active pharmaceutical ingredients ( Bulk Drugs ).

Part II: Requirements of plant and equipment.

Schedule N: List of Minimum Equipment for the Efficient Running of a Pharmacy

Schedule O: Standard for Disinfectant Fluids

Schedule P: Life Period of Drugs

Schedule P1: Pack Sizes of Drugs

Schedule Q: List of Dyes, colours and Pigments permitted to be used in Cosmetics and Soaps as given under IS : 4707 (Part I)-1988 as amended by the Bureau of Indian Standards

Schedule R: Standards for condoms made of rubber latex intended for single use and other mechanical contraceptives

Schedule S: Standard for cosmetics.

Schedule T: Good manufacturing practices for Ayurvedic, Siddha and all Unani medicines.

Schedule U: I – Particulars to be shown in the manufacturing records.

                   II – Records of Raw Materials..

                   III – Particulars to be recorded in the analytical records.

Schedule U(I): I – Particulars to be shown in manufacturing records.

                       II – Records of Raw Material.

Schedule V: Standards for patent or proprietary medicines.

Schedule W: Omitted

Schedule X

Schedule Y: Requirements and guidelines for permission to import and/or manufacture of New Drug for sale or to undertake clinical Trials.