Description
PrymaLab · Research use only
HMG 75IU
Menotropins: urinary FSH and LH, labelled 75 IU of each activity, freeze-dried
Menotropins, also called human menopausal gonadotropin (hMG), is a urinary preparation that carries two pituitary glycoprotein hormones, follicle-stimulating hormone (FSH) and luteinizing hormone (LH). This vial is labelled 75 IU of FSH activity plus 75 IU of LH activity, supplied as a white freeze-dried cake. The research behind it deals with how gonadotropin potency is assigned by bioassay and with randomized comparisons of urinary and recombinant gonadotropins in assisted reproduction.
Specifications
| Property | Value |
|---|---|
| Compound | HMG (Menotropins) Human menopausal gonadotropin: urinary FSH and LH; potency assigned in IU by bioassay |
| CAS number | 61489-71-2 |
| Molecular formula | Not applicable (glycoprotein mixture) |
| Theoretical mass | FSH about 30 kDa and LH about 28.5 kDa glycoform averages |
| Sequence / structure | Co-purified glycoprotein heterodimers: FSH = common α-subunit (92 aa) + FSHβ (111 aa); LH = common α-subunit (92 aa) + LHβ (121 aa); cystine-knot fold; N-glycosylated. |
| Label claim | 75 IU/vial (75 IU FSH + 75 IU LH activity) |
| Form | Lyophilized (freeze-dried) powder or cake in a sealed glass vial with a rubber stopper and aluminium crimp cap |
| Storage, sealed | 2–8 °C, dark |
| Purity specification | 99.0% or higher by RP-HPLC |
| Lot certificate | Results for the lot now shipping are in the certificate panel on this page |
| Safety data sheet | PL-SDS-082 |
Two hormones, two unit figures
FSH and LH are both heterodimers built on the same common alpha subunit of 92 residues. They differ in the beta chain, 111 residues in FSH and 121 in LH, and both have the cystine-knot fold and N-linked glycans. The certificate reports LC-MS centroids of 30,084 Da for FSH and 28,577 Da for LH, close to their glycoform averages of about 30 and 28.5 kDa. The two label figures are activities assigned by bioassay, and the label gives no milligram equivalent for either.
The unit is an assay convention, and the choice of assay changes the answer. When the WHO set up its International Standard for pituitary FSH, in vivo bioassays from different laboratories agreed at about 80 IU per ampoule, in vitro bioassays and receptor assays at about 31, and immunoassays spread from 5 to 311. The standard’s unitage was based on the in vivo bioassay because that assay best identifies and defines the hormone1.
What the research covers
What menotropins contains
Menotropins is a preparation rather than a single compound: FSH and LH purified together from urine. The two hormones share a common alpha subunit and differ in their hormone-specific beta subunits, which is why one vial can carry two separately labelled activities. Most clinical research on menotropins compares it with recombinant FSH, which supplies FSH activity alone, and asks whether the added LH activity changes the response; Andersen and colleagues framed their 2006 trial around exactly that question2.
Randomized comparisons with recombinant FSH
That trial randomized 731 women undergoing IVF, after pituitary suppression with a GnRH agonist, to highly purified menotropins or recombinant FSH, with identical care before and after randomization, assessors blinded to the allocation and ongoing pregnancy rate as the primary end point2. More oocytes were retrieved after recombinant FSH (11.8 against 10.0), while a larger share of embryos reached top quality with menotropins (11.3% against 9.0%)2. At the end of stimulation estradiol was lower and progesterone higher in the recombinant FSH group, and the endometrium more often had a hyperechogenic pattern2. The authors established non-inferiority of menotropins on the primary end point but could not conclude superiority2.
Devroey and colleagues repeated the comparison in 2012 under different conditions: 749 women at 25 centers in seven countries, GnRH antagonist cycles and a compulsory single-blastocyst transfer, again with blinded assessors3. The end points were ongoing pregnancy, live birth and a set of pharmacodynamic measures. Non-inferiority was established again, and the two preparations differed significantly on several pharmacodynamic end points3. A Cochrane review by van Wely and colleagues set out to pool every randomized trial comparing recombinant FSH with the three main urinary preparations (menotropins, purified FSH and highly purified FSH) under one set of inclusion criteria, because earlier systematic reviews had used different criteria and reached conflicting results4.
Stability of a protein preparation
FSH and LH are glycoproteins of around 30 kDa, so their stability follows protein chemistry rather than that of short peptides. Manning and colleagues reviewed the chemical and physical instability of protein pharmaceuticals, the ways each is controlled in aqueous solution and in the dried state, and how the two kinds of instability affect each other5. The review is general background. None of the papers here measured the stability of menotropins itself.
What is not established
The clinical trials used pharmaceutical highly purified menotropins in clinical settings, and their results describe those preparations, not this vial. The abstracts do not say which molecules supply the LH-type activity in a menotropins preparation, and none of the cited work studies FSH or LH receptor pharmacology directly. No paper here used PrymaLab material. Human chorionic gonadotropin, a related glycoprotein hormone built on the same kind of alpha subunit, is covered in the hCG guide.
How each lot is tested
Every lot is tested in PrymaLab’s own laboratory in Ashland, Kentucky before release: RP-HPLC for purity, LC-MS for identity, Karl Fischer titration for water, LAL for endotoxin and USP <71> for sterility. The results for the lot now shipping are in the certificate panel on this page, and the certificate number, key and QR code can be checked on the verify page. These are in-house results from PrymaLab Analytical, not an independent test, and the lab is not accredited to ISO 17025. The third-party testing guarantee on this page still applies: if any independent laboratory finds the wrong compound, or less than the stated purity or amount, the order is refunded and the cost of the test is reimbursed.
Frequently asked questions
What do the two 75 IU figures on the label mean?
They are activities, not weights: 75 IU of FSH activity and 75 IU of LH activity, each assigned by bioassay against a reference preparation. The certificate identifies both hormones by mass, FSH at about 30 kDa and LH at about 28.5 kDa, but the label gives no milligram figure.
How does the vial differ from the hMG pen?
The vial is a freeze-dried cake that stays dry until your laboratory needs it in solution. The pen is a 3 mL cartridge already in bacteriostatic water with 0.9% benzyl alcohol, labelled 150 IU per pen. Both are kept at 2 to 8 °C, and the pen must never be frozen.
How should the sealed vial be stored?
At 2 to 8 °C and in the dark, the certificate's condition for this glycoprotein preparation. Let it reach room temperature before opening so moisture does not condense on the cake. A solution is kept at 2 to 8 °C away from light, for a period your laboratory has established.
Do the IVF trials say anything about this product?
Only as background on the compound. Those trials used pharmaceutical highly purified menotropins in clinical settings and compared them with recombinant FSH. None of them tested PrymaLab material, and their findings cannot be carried over to a research vial.
Is HMG for human or veterinary use?
No. It is sold only for laboratory research. It is not approved for use in people or animals by the FDA or any other authority and must not be given to either.
References
- Storring PL, Gaines Das RE. The International Standard for Pituitary FSH: collaborative study of the Standard and of four other purified human FSH preparations of differing molecular composition by bioassays, receptor assays and different immunoassay systems. J Endocrinol. 1989;123(2):275-93. DOI · PubMed
- Andersen AN, Devroey P, Arce JC. Clinical outcome following stimulation with highly purified hMG or recombinant FSH in patients undergoing IVF: a randomized assessor-blind controlled trial. Hum Reprod. 2006;21(12):3217-27. DOI · PubMed
- Devroey P, Pellicer A, Nyboe Andersen A, et al. A randomized assessor-blind trial comparing highly purified hMG and recombinant FSH in a GnRH antagonist cycle with compulsory single-blastocyst transfer. Fertil Steril. 2012;97(3):561-71. DOI · PubMed
- van Wely M, Kwan I, Burt AL, et al. Recombinant versus urinary gonadotrophin for ovarian stimulation in assisted reproductive technology cycles. Cochrane Database Syst Rev. 2011;2011(2):CD005354. DOI · PubMed
- Manning MC, Chou DK, Murphy BM, et al. Stability of protein pharmaceuticals: an update. Pharm Res. 2010;27(4):544-75. DOI · PubMed
Research use only
For laboratory research use only. HMG 75IU is not a drug, food, cosmetic or dietary supplement, is not approved by the FDA or any comparable authority for human or veterinary use, and must not be given to people or animals. It is sold to qualified researchers and institutions, and the buyer is responsible for lawful handling and disposal.
Other formats of HMG
HMG is also stocked as hMG (Menotropins) 150IU preloaded 3ml pen, HCG 5000iu and HCG 10000iu. Each listing states its own quantity and concentration, and the pen and vial comparison explains what changes between formats.
Reviews
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