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Standard

In the analysis work, it often demanded to apply high-quality compound with the exact content being accurate in order to be compared as the detection control or used to calibrate the instrument, the compound is known as standard sample.
Standard refers to the standard substance used for measuring the potency of biological products. When the production department submits to a higher authority for approval of the quality standard of the biological product, they should also provide the standard sample (indicated in unit (μ)) used for measuring the potency of the tested product.

According to different application, the verification products can be divided into biological standard for the testing of biological products, endocrine drugs, antibiotics and other bioassay and chemical standards including:
1 chemical standards used for calibration of the instrument;
2 chemical reference standards used for calibration of the ultraviolet or infrared spectrum of the drugs;
3 control standards used for the purity test of drugs as well as the impurity control or as the control standards for content determination of the medicine.

In the page 67 of the appendix in the People's Republic of China Pharmacopoeia 1990 1st edition, we can find hundreds kinds of standards including bornyl ester acetate, eugenol and panaxadiol as well as 39 kinds of control medicine for the purify inspection of traditional Chinese medicine, impurity control or the content determination.

International standards
This refers to standard sample, with the potency units of the existing international standard sample potency units as baseline, undergoing further calibration of its potency units on the basis of a wide range of international cooperation. Its potency is expressed in 1U. For a certain product, for the establishment of the first international standard sample, the determination of its potency units should be consulted and decided by the Committee of Experts before the announcement. The international standard is a standard reference substance for worldwide preparation of national standards, so that the international standards can achieve unity.

Reagents and standards
All reagents in the food analysis laboratories should be clearly labeled to indicate the following: 1 name; 2 the date of preparation; 3 Signature from the people in charge; 4 if necessary, we need to add content such as safety and validity and so on.
Most food analysis should use standard sample as reference for qualitative and quantitative determination. The standard sample should be classified according to the following classification methods: 1 international standard; 2 national standards; 3 internal standard; 4 other standards.
Receptacle for reference standards should be clearly affixed to the label, to indicate the following: 1 name; 2 standard document number; 3 Opening times; 4 Validity; 5 Signature.
In addition, the laboratory should keep all the necessary specific files for all the necessary reference standards.
Capacity analysis standard solution should also be strictly managed. It should be clearly posted on all the standard solution containers with labels to indicate: 1 name; 2 concentration; 3 formulation date; 4 No of formulated procedures; 5 storage conditions; 6 validity; 7 Signature from people in charge.

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Structure Chemical Name CAS MF
Clindamycin Impurity 17 Clindamycin Impurity 17
Edaravone Impurity 12 Edaravone Impurity 12 2061958-41-4 C12H16N2O2
Empagliflozin Impurity 19 Empagliflozin Impurity 19
Erythromycin impurity D Erythromycin impurity D
FeBuxostat Impurity 40 FeBuxostat Impurity 40
Formoterol Impurity 13 Formoterol Impurity 13 150513-24-9 C18H24N2O3
Fosaprepitant Impurity 4 Fosaprepitant Impurity 4 1523569-85-8 C37H34F7N4O6P
Fudosteine Impurity 2 Fudosteine Impurity 2 1480319-53-6 C6H13NO5S
Ilaprazole Impurity 1 Ilaprazole Impurity 1
Ilaprazole Impurity 2 Ilaprazole Impurity 2
Isavuconazole Impurity 10 Isavuconazole Impurity 10
Isavuconazole Impurity 18 Isavuconazole Impurity 18
Isavuconazole Impurity 6 Isavuconazole Impurity 6
Lercanidipine Impurity 4 Lercanidipine Impurity 4 2727061-30-3 C18H23NO2
Nitrendipine Impurity 4 Nitrendipine Impurity 4
Olaparib Impurity 6 Olaparib Impurity 6
Paclitaxel EP Impurity H Paclitaxel EP Impurity H
Paroxetine Impurity 10 Paroxetine Impurity 10
1,2-Ethanediamine, N,N,N',N'-tetrakis(2-aminoethyl)- 1,2-Ethanediamine, N,N,N',N'-tetrakis(2-aminoethyl)- 4097-90-9 C10H28N6
Omeprazole EP Impurity G Omeprazole EP Impurity G 125656-83-9 C16H13N3O2S
Piperazine, 1-methyl-4-[(4-methyl-1-piperazinyl)carbonyl]- Piperazine, 1-methyl-4-[(4-methyl-1-piperazinyl)carbonyl]- 4180-30-7 C11H22N4O
Posaconazole Impurity 31 Posaconazole Impurity 31
Posaconazole Impurity 60 Posaconazole Impurity 60 2134652-05-2 C14H14F2O4
Regorafenib impurity D Regorafenib impurity D
SofosBuvir impurity 21 SofosBuvir impurity 21 1496552-50-1 C22H29ClN3O9P
sofosBuvir impurity 36 sofosBuvir impurity 36
SofosBuvir Impurity 52 SofosBuvir Impurity 52
SofosBuvir Impurity 59 SofosBuvir Impurity 59
Ticagrelor impurity 25 Ticagrelor impurity 25
Tirofiban Impurity 14 Tirofiban Impurity 14 1103300-75-9 C12H17NO5S
Tirofiban Impurity 19 Tirofiban Impurity 19 158808-75-4 C18H28N2O3
Amoxicillin Impurity  P Amoxicillin Impurity P C16H19N3O5S
Ampicillin Impurity S Ampicillin Impurity S
Cefdinir Impurity F (CP) Cefdinir Impurity F (CP)
Flucloxacillin Sodium Impurity A Flucloxacillin Sodium Impurity A 68728-50-7 C19H20ClFN3NaO6S
Oxacillin Sodium Impurity G(EP) Oxacillin Sodium Impurity G(EP) 724695-30-1 C19H18ClN3O5S
Spectinomycin Impurity D Spectinomycin Impurity D
(4R,4aS,5aR,12aS)-9-[2-(tert-butylamino)acetamido]-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide (4R,4aS,5aR,12aS)-9-[2-(tert-butylamino)acetamido]-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide C29H39N5O8
Amifostine Impurity 3 Amifostine Impurity 3 41510-53-6 C5H15N2O3PS
Cefradine impurity C Cefradine impurity C
Cefuroxime sodium impurity H Cefuroxime sodium impurity H C16H16N4NaO8S
Bilastine N-Oxide Bilastine N-Oxide 2069238-47-5 C28H37N3O4
Cefoxitin impurity F Cefoxitin impurity F
Tenofovir Disoproxil Fumarate impurity N Tenofovir Disoproxil Fumarate impurity N 1962114-92-6 C29H44N10O14P2
Prednisolone Impurity 7 Prednisolone Impurity 7 61549-70-0 C21H26O6
Tenofovir Related Compound 10 Tenofovir Related Compound 10 16958-60-4 C8H11N5O
N-(4-methyl-3-(N-(4-(pyridin-3-yl)pyrimidin-2-yl)acetamido)phenyl)-4-((4-methylpiperazin-1-yl)methyl)benzamide N-(4-methyl-3-(N-(4-(pyridin-3-yl)pyrimidin-2-yl)acetamido)phenyl)-4-((4-methylpiperazin-1-yl)methyl)benzamide C31H33N7O2
N1-benzyl-N1,4-dimethyl-N3-(4-(pyridin-3-yl)pyrimidin-2-yl)benzene-1,3-diamine N1-benzyl-N1,4-dimethyl-N3-(4-(pyridin-3-yl)pyrimidin-2-yl)benzene-1,3-diamine C24H23N5
(E)-4-(((5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3- yl)methyl)(methyl)amino)-4-oxobut-2-enoic acid (E)-4-(((5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3- yl)methyl)(methyl)amino)-4-oxobut-2-enoic acid C21H18FN3O5S
6-methyl-2-oxo-5-pyridin-2-yl-1H-pyridine-3-carbonitrile 6-methyl-2-oxo-5-pyridin-2-yl-1H-pyridine-3-carbonitrile 106637-42-7 C12H9N3O
Levofloxacin Impurity 15 Levofloxacin Impurity 15 94714-58-6 C14H12F4O4
Losartan Impurity 2 Losartan Impurity 2 1407521-00-9 C22H20ClN3O
Epoxy Exemestane (6-Alfa Isomer) Epoxy Exemestane (6-Alfa Isomer) 152764-24-4 C20H24O3
6-Cyclopropyl-10-fluoro-7,8-dihydrobenzo[k]phenanthridine 6-Cyclopropyl-10-fluoro-7,8-dihydrobenzo[k]phenanthridine 1187966-94-4 C20H16FN
Irbesartan IMpurity E Irbesartan IMpurity E C25H28N6O
LeflunoMide EP IMpurity G LeflunoMide EP IMpurity G 724429-16-7 C12H12N2O2
Telmisartan impurity C Telmisartan impurity C
Itraconazole iMpurity E Itraconazole iMpurity E
Edoxaban Isomer (RRR) Edoxaban Isomer (RRR) 1255529-24-8 C24H30ClN7O4S
1-NaphthaleneacetaMide, 1,2,3,4-tetrahydro-7-Methoxy- 1-NaphthaleneacetaMide, 1,2,3,4-tetrahydro-7-Methoxy- 92041-01-5 C13H17NO2
1,4,7,10-Tetraazacyclododecane-1,7-diacetic acid 1,4,7,10-Tetraazacyclododecane-1,7-diacetic acid 112193-75-6 C12H24N4O4
7-ethyl-5H-chroMeno[2,3-b]pyridin-5-one 7-ethyl-5H-chroMeno[2,3-b]pyridin-5-one 53944-31-3 C14H11NO2
2-Methyl-10H-thieno[2,3-b][1,5]benzodiazepin-4-aMine 2-Methyl-10H-thieno[2,3-b][1,5]benzodiazepin-4-aMine 612503-08-9 C12H11N3S
IMp. A (EP): 8-Chloro-5,10-dihydro-11H-dibenzo[b,e][1,4]diazepin-11-one IMp. A (EP): 8-Chloro-5,10-dihydro-11H-dibenzo[b,e][1,4]diazepin-11-one
IMp. C (EP): 8-Chloro-11-(piperazin-1-yl)-5H- dibenzo[b,e][1,4]diazepine IMp. C (EP): 8-Chloro-11-(piperazin-1-yl)-5H- dibenzo[b,e][1,4]diazepine
21-Dehydro-16α-hydroxy Prednisolone 21-Dehydro-16α-hydroxy Prednisolone 1188271-73-9 C21H26O6
(6α,11β)-11,20-Dihydroxy-6-Methyl-3-oxopregna-1,4,17(20)-trien-21-al (6α,11β)-11,20-Dihydroxy-6-Methyl-3-oxopregna-1,4,17(20)-trien-21-al 1338549-02-2 C22H28O4
Paroxetine IMpurity Paroxetine IMpurity
7-[(2-aMinoethyl)aMino] -1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid 7-[(2-aMinoethyl)aMino] -1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid C14H16FN3O3
(S)-(1R,3s,5S)-8-Methyl-8-azabicyclo[3.2.1]oct-6-en-3-yl 3-hydroxy-2-phenylpropanoate (S)-(1R,3s,5S)-8-Methyl-8-azabicyclo[3.2.1]oct-6-en-3-yl 3-hydroxy-2-phenylpropanoate 61616-97-5 C17H21NO3
AlviMopan iMpurity AlviMopan iMpurity
Caspofungin iMpurity Caspofungin iMpurity
Saxagliptin iMpurity Saxagliptin iMpurity 2173146-35-3 C18H24ClN3O2
Chlorocriptine Chlorocriptine 68944-88-7 C32H40ClN5O5
PD 312237 PD 312237 501666-23-5 C20H35NO11
(1R,5S,6S)-rel-5-(1-Ethylpropoxy)-7-oxabicyclo[4.1.0]hept-3-ene-3-carboxylic Acid Methyl Ester (1R,5S,6S)-rel-5-(1-Ethylpropoxy)-7-oxabicyclo[4.1.0]hept-3-ene-3-carboxylic Acid Methyl Ester 1234858-94-6 C13H20O4
2-(DiethylaMino)-N-(2,3-diMethylphenyl)acetaMide Hydrochloride 2-(DiethylaMino)-N-(2,3-diMethylphenyl)acetaMide Hydrochloride 857170-72-0 C14H23ClN2O
4-Hydroxy Darunavir 4-Hydroxy Darunavir 313682-97-2 C27H37N3O8S
Deschloroaripiprazole Deschloroaripiprazole 203395-81-7 C23H28ClN3O2
(S)-IsotiMolol (TiMolol IMpurity B) (S)-IsotiMolol (TiMolol IMpurity B) 158636-96-5 C13H24N4O3S
Afatinib IMpurity A Afatinib IMpurity A
Afatinib IMpurity G Afatinib IMpurity G
Articaine IMpurity F (Articaine Acid PropionaMide HCl) Articaine IMpurity F (Articaine Acid PropionaMide HCl)
Avanafil iMpurity 4 Avanafil iMpurity 4 874482-97-0 C8H11Cl2NO
Clopidogrel IMpurity 4 Clopidogrel IMpurity 4 801319-16-4 C15H14ClNO2S
Dehydro Azelnidipine Dehydro Azelnidipine 918659-10-6 C33H32N4O6
DiazepaM IMpurity F DiazepaM IMpurity F 31269-33-7 C16H13ClN2O
LaMotrigine IMpurity LaMotrigine IMpurity
Posaconazole DiastereoisoMer interMediate 5 Posaconazole DiastereoisoMer interMediate 5 149809-42-7 C21H21F2N3O4S
Prasugrel alpha-Hydroxy IMpurity Prasugrel alpha-Hydroxy IMpurity 1100905-45-0 C11H11FO2
Solifenacin Related CoMpound 2 Succinate Solifenacin Related CoMpound 2 Succinate 1262506-09-1 C27H32N2O6
Tetrahydro FuroseMide Tetrahydro FuroseMide 4793-38-8 C12H15ClN2O5S
6-O-DesMethoxyethyl-6-O-chloroethyl Erlotinib Hydrochloride 6-O-DesMethoxyethyl-6-O-chloroethyl Erlotinib Hydrochloride 183320-04-9 C21H21Cl2N3O3
LincoMycin 2-Phosphate LincoMycin 2-Phosphate 27480-30-4 C18H35N2O9PS
Macitentan IMpurity Macitentan IMpurity 556796-88-4 C17H15Br2N5O4S
4-((4-broMophenyl)(1H-1,2,4-triazol-1-yl)Methyl)benzonitrile 4-((4-broMophenyl)(1H-1,2,4-triazol-1-yl)Methyl)benzonitrile 143030-54-0 C16H11BrN4
Acetic acid, 2-[2-[4-(diphenylMethyl)-1-piperazinyl]ethoxy]- Acetic acid, 2-[2-[4-(diphenylMethyl)-1-piperazinyl]ethoxy]- 83881-53-2 C21H26N2O3
Apremilast Apremilast 1384439-80-8 C17H16N2O6S
TROXACITABINE TROXACITABINE 145511-98-4 C8H11N3O4
XXZJUZXKBFUPQH-IKGGRYGDSA-N XXZJUZXKBFUPQH-IKGGRYGDSA-N 1618657-31-0 C18H17FO4
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