GUIDELINE FOR RESIDUAL SOLVENTS

Q3C(R8)

buffer solution

A buffer solution is an acid or a base aqueous solution consisting of a mixture of a weak acid and its conjugate base, or vice versa. Its pH changes very little when a small amount of strong acid or base is added to it

What is call Liniarity

The linearity of an analytical procedure is its ability (within a given range) to obtain test results which are directly proportional to the concentration (amount) of analyte in the sample.

Compartment of HPLC & GC ?

HPLC

Going into more detail, HPLC consists of a variety of components, including a solvent delivery pump, a degassing unit, a sample injector, a column oven, a detector, and a data processor.

GC

GC uses an inert or unreactive carrier gas as the mobile phase, and the stationary phase is generally a thin layer of liquid. As the mobile phase moves, it separates the mixture into its individual components in the stationary phase

What is call Mass spectroscopy

Mass spectrometry (MS) is an analytical technique that separates ionized particles such as atoms, molecules, and clusters by using differences in the ratios of their charges to their respective masses (mass/charge; m/z), and can be used to determine the molecular weight of the particle

What is the most useful range of IR?

between 4000 – 670cm^–1

Give name reaction

1. Aldol Condensation: We can define aldol condensation as an organic reaction in which an enolate ion reacts with a carbonyl compound to form β-hydroxy aldehyde or β-hydroxy ketone, followed by dehydration to give a conjugated enone.
2. Balz-Schiemann Reaction: The Balz-Schiemann Reaction is named after German scientists Günther Schiemann and Günther Balz. The reaction showcases the conversion of arylamines to aryl fluorides. The reaction happens through diazotization after which thermal decomposition of the derived hexafluorophosphate or tetrafluoroborates. Visit Balz-Schiemann Reaction for more information.
3. Cannizzaro Reaction: The Cannizzaro Reaction is named after Stanislao Cannizzaro. The chemical reaction signifies the base-induced disproportionation of a non-enolizable aldehyde. Click here for more information on Cannizzaro Reaction.
4. Clemmensen Reduction: The Clemmensen Reduction reaction is named after a Danish scientist, Erik Christian Clemmensen. The Clemmensen Reduction reaction shows how to reduce ketones or aldehydes to alkanes using zinc amalgam and hydrochloric acid.
5. Etard Reaction: The Etard Reaction is named after a French chemist named Alexandre Léon Étard. The Etard Reaction is a chemical reaction in which a heterocyclic bound or an aromatic methyl group is directly oxidized to an aldehyde using chromyl chloride. Visit Etard Reaction for more information.
6. Finkelstein Reaction: The Finkelstein Reaction is named after Hans Finkelstein, a German chemist. The Finkelstein Reaction deals with the exchange of a halogen atom by a Substitution Nucleophilic Bimolecular reaction. Click here for more information on Finkelstein Reaction.
7. Friedel Crafts Reaction: Friedel Crafts Reaction was developed by Charles Friedel and James Crafts in 1877. The Friedel – Crafts Reaction is a way of attaching substituents to an aromatic ring. Visit Friedel Crafts Reaction for an in-depth explanation of the reaction details and mechanism.
8. Gabriel Phthalimide Synthesis: Gabriel Phthalimide Synthesis was discovered by a German chemist named Siegmund Gabriel. The Gabriel synthesis is a chemical reaction used to obtain primary amines from primary alkyl halides.
9. Gattermann Reaction: The Gattermann Reaction is named after a German chemist, Ludwig Gattermann. Also known by the name, Gattermann salicylaldehyde synthesis is a chemical reaction in which aromatic compounds in the presence of a Friedel–Crafts catalyst are formylated by hydrogen cyanide.
10. Gattermann – Koch Reaction: The Gattermann–Koch reaction is named after the German chemists Julius Arnold Koch and Ludwig Gattermann. In a Gattermann–Koch reaction refers to a Friedel–Crafts acylation reaction in which a Friedel–Crafts catalyst, hydrochloric acid, and carbon monoxide are used to produce aromatic aldehydes from various aromatic compounds, including derivatives of naphthalene and benzene. Click here for an in-depth explanation of the reaction details and mechanism of Gattermann – Koch Reaction.
11. Grignard Synthesis: A Grignard Synthesis Reaction is a chemical reaction in which vinyl, alkyl, or aryl-magnesium halides (Grignard reagents) add to a carbonyl group of a ketone or aldehyde. Visit Grignard Synthesis for more information.
12. Kolbe’s Reaction: Kolbe’s Reaction is a chemical reaction where aromatic hydroxy acid is produced from the heating of sodium phenoxide with carbon dioxide under a pressure of about 100 atmospheres and the successful treatment of the resulting product with sulfuric acid. Click here for an in-depth explanation of the reaction details and mechanism of Kolbe’s Reaction
13. Reimer- Tiemann Reaction: Reimer- Tiemann Reaction was discovered by Karl Reimer and Ferdinand Tiemann. They have a private track to test the used for the ortho-formylation of phenols. Visit Reimer- Tiemann Reaction for more information.
14. Rosenmund Reduction: The Rosenmund reduction was named after Karl Wilhelm Rosenmund, who in 1918 reported its discovery. A hydrogenation process in which an acyl chloride is selectively reduced to an aldehyde.
15. Sandmeyer Reaction: The Sandmeyer Reaction was named after Traugott Sandmeyer in 1884. Sandmeyer Reaction is a chemical reaction in which we use aryl diazonium salts to synthesize aryl halides. Sandmeyer Reaction provides the capability of performing some unique transformations to benzene such as hydroxylation, trifluoromethylation, cyanation, and halogenation.
16. Stephen Reaction: Also known by the name, Stephen aldehyde synthesis, was discovered by Henry Stephen. This chemical reaction involves the preparation of aldehydes from nitriles using tin(II) chloride, hydrochloric acid and quenching the resulting iminium salt with water. During the synthesis, ammonium chloride is also produced. Click here for an in-depth explanation of the reaction details and mechanism of Stephen Reaction.
17. Swartz Reaction: Swarts reaction and Finkelstein reactions are halogen exchange reactions that are associated with alkyl halides. Visit Swartz Reaction for more details.
18. Williamson Synthesis: This a chemical reaction to implement ether synthesis discovered by Alexander Williamson in 1850. The Williamson ether synthesis is a chemical reaction for forming an ether from an organohalide and deprotonated alcohol.
19. Wolff – Kishner Reduction: The Wolff – Kishner Reduction reaction was first reported by Nikolai Kishner in 1911 and Ludwig Wolff in 1912. This is a named reaction in organic chemistry involving obtaining methylene groups by converting carbonyl functionalities. Click here for an in-depth explanation of the reaction details and mechanism of Wolff – Kishner Reduction.
20. Wurtz Reaction: The Wurtz reaction, named after Charles-Adolphe Wurtz, is a coupling reaction in organic chemistry, organometallic chemistry and recently inorganic main group polymers, whereby two alkyl halides are reacted with sodium metal in dry ether solution to form a higher alkane. Visit Wurtz Reaction for more information.
21. Wurtz – Fittig Reaction: The Wurtz–Fittig reaction is the chemical reaction of aryl halides with alkyl halides and sodium metal in the presence of dry ether to give substituted aromatic compounds. Click here for more information on Wurtz Fittig Reaction.
22. Carbylamine Reaction: The Carbylamine reaction is also known as Hofmann isocyanide synthesis. It is the reaction of a primary amine, chloroform and a base to synthesize isocyanides. Click here for an in-depth explanation of the reaction details and mechanism of Carbylamine Reaction.
23. Fischer Esterification: Fischer Esterification is an organic reaction which is employed to convert carboxylic acids in the presence of excess alcohol and a strong acid catalyst to give an ester as the final product. Visit Fischer Esterification for more information.
24. Haloform Reaction: The Haloform reaction is a chemical reaction where haloforms are produced by the exhaustive halogenation of methyl aldehyde or methyl ketone with a base present. Click here for more information on Haloform Reaction.
25. Hell-Volhard-Zelinsky Reaction: The Hell-Volhard-Zelinsky reaction is used for the halogenation of carboxylic acids at the alpha carbon. Click here for an in-depth explanation of the reaction details and mechanism of Hell-Volhard-Zelinsky Reaction.
26. Hoffmann Bromamide Reaction: The Hoffmann Bromamide reaction is used for the conversion of a primary amide to a primary amine with one less carbon atom.

QC Department

Different between iodimatry and iodomatry titration

Iodometry is a titration in which the reducing agent is utilised to titrate the iodine formed in the preceding redox reaction, whereas iodimetry is a titration in which the reducing agent is used to titrate the iodine solution directly.

back titration

A back titration is a titration method where the concentration of an unknown compound is determined by reacting with a known amount of excess reagent. A back titration is also called indirect titration. There is a chemical reaction between these compounds.

Check out “Pharma Interview”

Method validation USP chapter<1225>

Typical Analytical Characteristics Used in Method Validation

• Accuracy
• Precision
• Specificity
• Detection limit
• Quantitation limit
• Linearity
• Range
• Robustness

Aurobindo Pharmaceutical Limited|| USFDA give 483 ||AUGUST- 2022

Aurobindo Pharma on Tuesday said the US health regulator has issued Form 483 with three observations after inspecting its manufacturing facility at Pydibhimavaram in Andhra Pradesh.

As per US Food and Drug Administration (USFDA), Form 483 is issued to a firm’s management at the conclusion of an inspection when the investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

The Pydibhimavaram unit was classified as OAI (official action indicated) on May 17, 2019, and subsequently given a warning letter on June 20, 2019 by the USFDA, Aurobindo Pharma said in a regulatory filing.

Subsequently, the company said it has responded to the warning letter and carried out the committed corrections and the USFDA authorities inspected the facility from July 25 to August 2, 2022.

”At the end of the inspection, we have been issued a Form 483 with three observations and none of these observations are related to data integrity,” Aurobindo Pharma said.

The company will respond to the USFDA within the stipulated timeline and work closely with the regulator to address the observations at the earliest, it added.

The unit is a non-antibiotic active pharmaceutical ingredients manufacturing facility.

Links observation

Analytical method validation

• Method: method validation
VIM
• Measurement procedure: procedure validation
GLP

• Standard operation procedure: SOP validation