Lebsa - Your APIs Manufacturer

Standard products

Upon request

Developing products

LEBSA | Crta. de l’Hospitalet, 34 • 08940 Cornellà (Barcelona) SPAIN • Tel. 34 93 377 00 51 · Fax 34 93 377 51 58 • leb@lebsa.com

LEBSAResearch, development and synthesis of organic chemical productsLebsaLEBSA es una empresa fundada en 1951 y dedicada a la investigación, desarrollo y síntesis de productos químicos orgánicos. LEBSA tiene como objetivo la síntesis de nuevas moléculas con aplicaciones terapéuticas y el estudio de nuevos procesos de síntesis para moléculas ya conocidas.ControlLEBSA aplica a todos sus productos un riguroso proceso de control (G.M.P.); por su pureza y perfecta correspondencia con sus especificaciones, sus fabricados son muy bien aceptados en el mercado interior y exportados a todo el mundo.ProducciónLEBSA está equipada con reactores polivalentes de vidrio, acero inoxidable y esmaltados, de tamaños comprendidos entre 10 y 1.600 l. y dotados de todos los servicios necesarios. LEBSA puede ofrecer productos en muy diversas cantidades, desde pequeños lotes de ensayo, a algunas toneladas por año.FabricaciónLEBSA está especializada en la fabricación, per encargo, de Fine Chemicals para la Indústria Química Farmacéutica.productosstandard productionamisulpride FP-017.89
Ph Eur

Description.................. White crytalline powder

Melting Point................ 124 - 128ºC

IR Spectrum.................. Similar to standard

Solubility................... To pass test

Appearance of solution:

Clarity................. Not more than Ref.II

Colour.................. Not more than Ref.Y6

Optical rotation............. -0.10º to +0.10º

Impurity A TLC............... Max.: 0.1%

Related substances HPLC:

Individual impurities... Max.: 0.1% each

Total impurities........ Max.: 0.3%

2-Propanol................... Max.: 5000 ppm

Chlorides.................... Max.: 200 ppm

Heavy Metals................. Not more than 10 ppm

Loss on drying............... Not more than 0.5%

Sulphated ash................ Not more than 0.10%

Assay........................ 99.0 - 101.0%

betahistine dihydrochloride" FP-010.89
Ph Eur.
Identification

Description.................. Crystalline powder

I.R. Spectrum................ Similar to standard

Chlorides.................... Passes Test

Melting point................ 150 - 154 ºC

Tests

Opalescence.................. Passes Test

Colour....................... Passes Test

pH........................... 2.0 - 3.0

HPLC

Impurity A.............. Not more than 0.1%

Individual impurities... Not more than 0.2% each

Total impurities........ Not more than 0.5%

Ash.......................... Not more than 0.1%

Heavy metals................. Not more than 20 ppm

Loss on drying............... Not more than 1%

Assay........................ 99.0 - 101.0%

Residual ethanol............. Max: 1000 ppm

betahistine dimesilate FP-003.92
Ph Eur.

Description.................. White crystalline powder

Identification

Melting Point............... 108-112ºC

IR Spectrum................. Similar to standard

TLC......................... To pass test

Identification D............ To pass test

Appearance of solution....... Clear and colourless

pH........................... 2.0 - 3.0

Related substances HPLC

known impurities........ Not more than 0.2% each

Unknown impurities...... Not more than 0.1% each

Total impurities........ Not more than 0.5%

2-Propanol................... Not more than 5000 ppm

Chlorides.................... Not more than 35 ppm

Sulphates.................... Not more than 250 ppm

Heavy Metals................. Not more than 20 ppm

Water........................ Not more than 2.0%

Assay........................ 98.0 - 101.0 %

bromopride FP-013.89

Description........................... White powder

IR Spectrum........................... Similar to standard

Colour and opalescence of solution 10% To pass test

Loss on drying........................ Not more than 1.0%

pH 10%................................ 9 - 10

Melting point......................... 151 - 155ºC

Related substances (TLC).............. Not more than 0.5%

Heavy metals.......................... Not more than 20 ppm

Residue on ignition................... Not more than 0.10%

Assay................................. 98 - 102%

dequalinium chloride FP-001.97
Ph.Eur.

Description......................... White or yellowish-white powder

Identification

I.R. Spectrum.................. Similar to standard

Chlorides...................... To pass test

Tests

Appearance of solution......... Clear and colourless

Acidity or alkalinity.......... To pass test

Related substances HPLC

4-aminoquinaldine............ Not more than 1%

Total impurities............. Not more than 10%

Readily carbonisable substances To pass test

Loss on drying................. Not more than 7.0%

Sulphated ash.................. Not more than 0.1%

Residual acetone............... Not more than 0.5%

Assay............................... 95.0 - 101.0%

dibrompropamidine isetionate FP-007.95
Ph. Eur.

Description................... White powder

IR Spectrum................... Similar to standard

Identification B.............. To pass test

pH............................ 5.0 - 6.0

HPLC

Impurity A............... Not more than 0.3%

Impurity B............... Not more than 0.5 %

Unspecified impurities... Not more than 0.1% each

Total impurities......... Not more than 0.1%

Loss on drying 105 ºC......... Not more than 2.0%

Sulphated ash................. Not more than 0.1%

Assay......................... 99.0 - 101.0%

Residual acetone.............. Not more than 0.5%

propamidine isetionate FP-006.95

Appearance.................... White powder

IR Spectrum................... Similar to standard

Melting Point................. 237.0 - 242.0ºC

Colour........................ To pass test

Opalescence................... To pass test

Solubility.................... To pass test

pH............................ 5.0 - 7.0

Loss on drying................ Not more than 1.0%

HPLC Individual impurities.... Not more than 0.5% each

Total impurities......... Not more than 1.0%

Sulphuric ash................. Not more than 0.1%

Ammonium isetionate........... Not more than 1.0%

Residual acetone.............. Not more than 2500 ppm

Assay......................... 98.0 - 102.0%

sulpiride FP-001.89
Ph. Eur.

Appearance................... White powder

Identification

Melting Point .......... 177 to 181ºC

IR spectrum............. Similar to standard

Tests

Opalescence.................. To pass test

Colour....................... To pass test

TLC.......................... To pass test

HPLC

Known impurities........ Not more than 0.1% each

Unknown impurities...... Not more than 0.1% each

Total impurities........ Not more than 0.3%

Chlorides.................... Not more than 100 ppm

Iron......................... Not more than 10 ppm

Heavy metals................. Not more than 10 ppm

Loss on drying............... Not more than 0.5%

Sulphated ash................ Not more than 0.1%

Assay........................ 98.5 to 101%

tiapride hydrochloride FP-008.89
Ph. Eur.

Appearance................... White powder

Identification

IR spectrum............. Similar to standard

Chloride test........... To pass test

Appearance of solution: Clear Absorbance 450 nm less than 0.030

pH........................... 4.0-6.0

Impurity C (TLC)............. Not more than 0.1%

HPLC

Individual impurities... Not more than 0.1% each

Total impurties......... Not more than 0.3%

Heavy metals................. Not more than 20 ppm

Loss on drying............... Not more than 0.5%

Sulphated ash................ Not more than 0.1%

Assay........................ 98.5 - 101.0%

production under requestolsalazine sodium Ph. Eur.

Description .................. Yellow powder

Identification

IR Spectrum.................. Similar to standard

Sodium identification ....... To pass test

Acetate....................... Not more than 1.0%

Methanesulphonic acid......... Mot more than 0.3%

HPLC Related substances:

Individual impurites .... Not more than 1.0% (only one peak greater than 0.5%)

Total impurites ......... Not more than 2.0%

Heavy metals ................. Not more than 20 ppm

Loss on drying ............... Not more than 2.0%

Assay ........................ 98.0 - 102.0%

under developmentfluindione

Description................... White or almost white powder

Identification

IR spectrum.............. Similar to standard

Melting point............ 118 - 122ºC

Loss no drying................ Not more than 1.0%

Ash........................... Not more than 0.1%

Purity HPLC................... Not less than 99.0%

imidocarb dipropionate

Description................... White powder

IR spectrum................... Similar to standard

Melting point................. 202 - 206ºC

Purity HPLC................... Not less than 98.0%

Ash........................... Not more than 0.1%

itopride hydrochloride

Description................... White powder

Melting point................. 191-195ºC

IR spectrum................... Similar to standard

Cololur....................... Not more than Bq.

Opalescence................... Not more than Ref. I.

PH............................ 3.5 - 5.5

Loss on drying................ Not more than 1.0%

Ash........................... Not more than 0.1%

Purity HPLC................... Not less than 99.0%

Assay......................... Not less than 98.5%

lacidipine

Description................... White to pale yellow powder

IR Spectrum................... Similar to standard

2-propanol.................... Not more than 0.5%

HPLC

Identification........... Rt similar to standard

Impurity B .............. Not more than 0.2%

Other impurities ........ Not more than 0.2%

Total impurities ........ Not more than 0.5%

water......................... Not more than 0.2%

Assay......................... 97.5 - 102.0%

lofexidine hydrochloride

Description................... White powder

IR Spectrum................... Similar to standard

Loss on drying................ Not more than 1.0%

purity HPLC................... Not less than 99.0%

Assay......................... 98.0 - 102.0%

parvaquone

Description................... Yellow powder

Solubility.................... Passes test

I. R. spectrum................ Similar to standard

Melting point................. 133.0 - 137.0ºC%

HPLC

Individual impurities.... Nmt 1.0%

Total impurities......... Nmt 2.0%

Ash........................... Not more than 0.10%

Loss on drying................ Not more than 1.0%

Assay......................... 99.0 - 101.0%

picloxidine dichloride

Description................... White powder

Solubility.................... Soluble in water (1:1000)

Melting point................. About 281ºC

Loss on drying................ Not more than 2.0%

Ash........................... Not more than 0.1%

Heavy Metals.................. Not more than 20 ppm

Related substances............ Not more than 0.5%

pH............................ 4.0 - 6.0

p-Chloroaniline............... less than 200 ppm

Assay......................... Min. 97.5%

xipamide

Description................... White powder

IR Spectrum................... Similar to standard

Loss on drying................ Not more than 1.0%

Ash .......................... Not more than 0.1%

HPLC

Individual impurities.... Not more than 0.5%

Total impurities ........ Not more than 1.0%

linksIQS http://www.iqs.esUniversitat de Barcelona http://www.ub.eduDiseño y desarrollo: BR Innovation Branding